WO1987007969A2 - Computer automated sensory and motor function assessment - Google Patents

Abstract

Quantitative numerical profiles and graphical displays of human function/performance capabilities are produced from serial measurements derived from a battery of transducers which sense physical parameters in response to a visual, auditory, or mechanical stimulus and/or special task definition. In different aspects, a sufficient, selected subset of available measurements are administered, representative data is obtained and processed to yield one or several characteristic feature measures corresponding to functions such as strength, range of motion, speed, coordination, etc., and the quantitative functional profile is displayed as a formatted array of individual measures. In other aspects, statistical comparison arrays, representing a normalized version of the raw measure array, is generated. This array is used to produce one of several application dependent display formats, or to generate a functional profile visualization, relating combinations of individual normalized array elements directly to human anatomic (body) sites. In other aspects, the normalized array is used in combination with special knowledge and/or data bases to yield application dependent predictions related to various aspects of human performance.

Description

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COMPUTER-AUTOMATED SENSORY AND MOTOR FUNCTION ASSESSMENT

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The present invention 'is directed to an apparatus and method for pefforming human performance function assessments of human patients. In particμlar, the present invention is directed to a computer automated system for

20 evaluating and diagnosing human neurological function on the basis of automated neurological function tests.

The clinician, in carrying out the classic neurologic examination, applies principles of nervous system

25 structure and function to localize a lesion and arrive at a diagnosis. While numerous laboratory procedures and tests have been developed and applied clinically over the years, their aim is not to replace classic clinical examinations performed by therapists, orthopedists or

30 neurologists, but instead to complement and confirm infor¬ mation obtained by the neurologist.

However, the limitations of the classic neurologist examination prevent the objective and accurate assessment 35 of disabilities required for neuropharmacologic clinical trials or serially evaluating disease related function changes. Thus, examinations of neurologic function utilizing ordinal scales were developed as a means of "structuring" the human performance examination. This structured examination, like the classic examination, is dependent on the skilled but subjective judgment of a physician. Individual functions such as strength are assessed and rated on an ordinal scale, e.g. 1 = normal, 2 = mild, 3 = moderate abnormality, 4 = severe ab¬ normality, 5 = paralysis. Although this examination is simple to perform and can be quickly scored, the scale is too restricted to categorize small but important changes in function over time or to determine a patient's proportion of normal function. In addition, idiosyn¬ crasies of trained observers, along with the inherent subjectiveness of the tests and disagreement over the correspondence of scale numbers and degree of functional loss, ^'limit'critical comparison of results obtained from different sources.

In efforts to supplement coded examinations, investi¬ gators have developed more sensitive instrumented tests for functions such as strength, steadiness, reactions, speed, coordination, sensation, fatigue, gait, and station. While a variety of methods have been developed and documented (for review, refer to Potvin et al., (1981) 'Quantitative Methods in Assessment of Neurologic Function," CRC Rev. Bioenq. , 6(3) .177-224) , routine clinical use has yet to come about. This is most likely due to problems with current experimentally applied methods (time consuming, expensive, poorly documented and difficult to reproduce instrumentation, time consuming manual data management and reducing, lack of standardiza¬ tion, limited evaluation and application) and insufficient collaboration among neurologists, biomedical engineers, psychologists, statisticians, and medical technicians to consolidate development efforts. Therefore, there are few commercial devices available for assessment of individual functions and none that integrate tests into a system capable of broad neurologic function assessments.

The present invention is directed to an apparatus and method for diagnosing human function and performance capabilities. The apparatus' "system" incorporates a variety of motorsensory function tests which are mediated from a battery of transducers that^' sense physical para- meters in response to visual, auditory or mechanical stimulus and/or special task definitions. The transducers function to encode the patient's performance in the form of electronic impulses which are processed to produce a raw patient function data array or matrix. Generally speaking, this raw patient function data matrix can be viewed as a numerical listing of a patient's performance on a selected motorsensory test. For example, in a - particular test which measures a patient's forearm strength, the raw patient data matrix with respect to that patient's forearm strength will consist of a "raw" strength parameter in terms of the raw strength exerted. Similarly, for example, with respect to visual acuity, a patient's raw function matrix will consist of individu¬ alized parameters without regard to how that patient's parameters compare to other human populations.

The patient's "raw" function scores are next compared to scores achieved by selected human populations on the same neurologic test to standardize the patient's test performance in terms of a population comparison profile data matrix. Basically, this population profile matrix represents a standardized and formatted rendition of the patient's raw function array and thus provides a means of comparing the patient's performance to other selected individuals. Although the comparison matrix can be formatted in a number of ways depending on the use of which it will be put, the comparison array will normally be formatted and displayed in units of standard deviation from the selected population's performance. Thus, the patient's particular motorsensory function is "standardized" so that means of strength's and weaknesses with respect to other individuals can be readily identified.

In a further aspect of the present invention, a central human function and performance data matrix is provided to obtain diagnostic evaluation of the test subject's motorsensory function. The central matrix contains stored raw function arrays from selected human populations wherein the matrix is cataloged or indexed with respect to particular population function charac¬ teristics.

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Indexing may be in terms of population charac¬ teristics such as those populations exhibiting a parti- cular pathologic or neurologic affliction, or various recuperation stages of such infections. Alternatively, population function arrays may be indexed or characterized in terms of populations having pronounced functional capabilities such as athletes, dancers and the like. By coupling a particular patient's profile data or raw function data to population data indexed in the above manner, the particular patient's functional capabilities, or alternatively, the patient's neurologic maledy, may be characterized or "diagnosed".

FIG. 1. Block diagram of test battery data acquisition components and scheme.

FIG. 2. Block diagram for general basic realization of human performance/function measurement and evaluation system. FIG. 3. Schematic flow of information through the database system.

FIG. 4. Standard Comparison Report Example.

FIG. 5. Standard Composite Rating Report Example.

FIG. 6. Flow chart representing two-alternative forced choice method used in sensory tests.

FIG. 7a. Embodiment I flowchart for client/service provider/system interface detailing system functions and relationships between major components.

FIG. 7b . Embodiment II flowchart for client/service provider/system interface detailing system functions and relationships between major components.

FIG. 7c. Embodiment III flowchart for client/service provider/system interface detailing system functions and relationships between major components.

FIG. 7d. Embodiment IV flowchart for client/service provider/system interface detailing system functions and relationships between major components.

FIG. 8. Summary of functions measured and body sites involved in measurements which yields more than 500 unique measures of performance/function.

FIG. 9. Block diagram of further test battery interface/support hardware modules and specific peripheral stimulators and transducers.

FIG. 10 Detail of raw test result file formats and processing by DECIPHER Program to yield formatted. screened, and compressed data records (one record per test session) .

FIG. 11. Trend Report Example.

FIG. 12. Measurement Report Example.

FIG. 13. Summary diagram of administration software for test battery.

FIG. 14. Graphical display of a motorsensory function profile of 15 head-injury patients. Fig. 14a representsιthe average and range for the 15 patient population in each of twelve major function categories. Fig. 14b shows a similar plot for a patient 3 months post-injury. ^' Fig. 14c illustrates the function profile for a patient 27 months post-injury. _*

I. Systems Concept; Development and Key Features.

In order to minimize problems associated with prior attempts to quantitate and characterize neurological function, a broad battery of computer-based tests have been developed to quantitively assess human neurological function in an automated fashion that lends itself to standardization. Instrumentation and tests were developed with feature that are beneficial from the patient's, technician's, and clinician's viewpoints. For the patient's benefit, tests were developed that are simple in concept, adaptable to a wide range of disabilities, short in duration, interesting, and in some cases enjoyable. The patient-equipment interfaces (trans¬ ducers, stimulators) were made simple, comfortable, and safe so as to minimize patient anxiety. To simplify the technician's job, which is to monitor tests and aid the patient to perform tests according to instructions, tests were designed that maximize objec¬ tivity by requiring minimal technician involvement. A software monitor system with menus and prompts limits decision-making required during test administration. Data logging and file naming were automated with expandable and standardized formats to eliminate data loss and/or errors encountered with manual methods and to permit recording of more parameters for increase assessment yield. Software- implemented error checking is provided to catch obvious errors when keyboard entries are required.

To be more meaningful and useful to the clinician, easy to interpret single number scores that accurately and reliably quantify the desired functions are computed for most tests. A specially formatted printout of reduced data for immediate inclusion in permanent patient records is also utilized. Large population scores can also be analyzed without manual data handling, making the system attractive to physicians in different settings. All tests can be administered by a trained technician, who is independent of patient treatment and interpretation of results.

With these goals in mind, instruments were designed and constructed with state-of-the-art technology. To facilitate reproduction, printed circuits were designed for much of the electronics. Consequences of implementing specific segments of a given test with hardware or soft¬ ware were carefully evaluated. This provides a more compact and efficient system since instrumentation sub¬ systems are used for several different tests. Tests are integrated into a console station system centered around a minicomputer. Software is structured so that it is efficient for clinical use with default parameters and sufficiently flexible for research with keyboard selection of parameters. Design attention was given to development of a system composed of expandable an easy-to-modify hardware and software to meet changing needs and allow simple addition of new tests. For a review of in-depth methods and applications of the present invention, see Kondraske et al. (1986) Proceedings, IEEE Engineering, Medicine and Biology Society, Fort Worth, incorporated herein by reference.

Table 1 presents a list of system components, test devices and accessories useful in implementing the computer automated system of the present invention. Tests which incorporate these components are described in detail in later sections.

TABLE 1 List of possible system components. Item Description

1. Main Computer Console

2. Video Graphics Display

3. Computer Terminal

4. Eye Chart

5. Upper Extremity Reaction-Tapping Board

6. Lower Extremity Reaction-Tapping Board

7. Joystick

8. Tremor Frame

9. Force Platform

10. Strength Transducers a) Grip b) Universal

11. Pronation/Supination Device

12. Sensory Console

13. Touch/Pressure Aesthesio eter

14. Headphones

1.5. Finger/Wrist Driver _#

16: Ankle Driver

17. Elbow/Knee Driver

18. Biocurve Tracer

19. Microphone

20. Activity of Daily Living Accessories a) XL man's flannel shirt b) Large Button board c) Small button board d) Zipper board e) Large needle (7.6 cm long, eye - .95 CM lo f) 2 standard safety pins (3.8 cm long) g) Shoelace board

21. Manual Dexterity Accessories a) Purdue Pegboard with 8 small pegs b) 8 large pegs and board

22. Heel Support Accessory for Foot Dorsiflexion Stre

23. Arm Support Accessory for Hand Resting Tremor

24. Examination Table

25. Instrumented Skinfold Calipers Table 2 summarizes major functional categories which are-possible to test and includes a brief operational description of the test method employed. Measurement of this breadth is obtained through the use of the individual test devices. Some test devices are used in different scenarios to obtain more than one measure of function through selection of different tests. Likewise, one test execution may result in the acquisition of several measures.

Table 3 provides a useful cross reference between functions measured, test devices, software commands (for test selection), and measures obtained from a given device. Note that a working definition is used for measures. Detailed description of how devices are used in test scenarios for measurement of different functions, as well^'.as data acquisition factors, signal processing, . definitions of measures, and how each is computed is discussed in a later section as is a description of each device.

The software commands listed represent primary commands for selection of tests, that once entered, generate specific prompts (questions with a limited set of responses) or menus (a list of available test options) to allow further definition of a specific test mode within the framework of the command selected. In most cases, responses t prompts are used to properly "label" the test result in the computer (for example, as a right side, upper extremity result). TABLE 2

Summary of major function categories, test modes and body sites, and operational description of method employed.

MAJOR CATEGORY AND MEASUREMENT OPTIONS DESCRIPTION OF TESTS

MENTAL STATUS

Short term memory The test is based on subject responses to random sequence of light patterns up to 10 items in length. The subject responds by remembering the pattern and touching sensors to duplicate the light sequences or by vocally repeating the sequence.

General Based on number of correct responses to a standardized 10 question mental status questionnaire.

VISION

Corrected visual efficiency Visual acuity determined with a Snellen chart and converted to standard central visual efficiency.

AUDITION

High and low frequency tones This hearing test is based on threshold levels for low and high frequency tones, administered through head phones. SPEECH

A wide range of factors While the subject carries out related to speech motor carefully defined speech tasks, function (reaction time, acoustical data is processed to arrive respiratory function, at individual measures of the phonatory strength, particular aspect of speech function localized phonatory and being measured. articulatory speech and coordination).

SENSATION

Vibration A subbattery of tests based on

Thermal traditional sensory testing of

Touch selected body sites. The threshold

Position level at which the subject is able to

Motion (kinesthesia) correctly identify the presence or

Two-point discrimination absence of a stimulus 50% of the time is determined. The two-alternative, forced choice method is used in conjunction with computer controlled, precisely generated stimuli and processing of subject responses.

ANIHROPOMETRIC FEATURES

Body segment lengths Based on the body landmark oriented Circumference at selected approach, instrumented measurements sites- are made with a coordinate digitizer called the Biocurve Tracer. RANGE OF MOTION

Selected motions are most Based on and similar to goniometric body sites: measurements, degrees of active or passive joint range of motion measured

Neck Elbow Hip with an instrumented, jointed

Spine Forearm Knee mechanical arm device (the Biocurve

Shoulder Wrist Ankle Tracer).

ISOMETRIC STRENGTH

Selected motions at many body Based on traditional manual muscle sites for a total set of testing techniques, but performed with approximately 90 different hand-held force transducers and with measures. results recorded as percent body weight (kilograms of force per kilogram of body weight) .

SPEED

Tapping Based on the number of taps in 10

Upper and lower extremity seconds recorded on a touch sensitive pad with various body sites (finger, hand, arm, foot) involved.

Forearm Quantification of the typical rapidly

Supination/pronation alternating forearm supination-pronation test measured as average velocity in degrees per second of excursion during a 10 second trial.

Movement time Based on time elapsed in moving

Upper and lower extremities between two points in response to a and body weight shift in visual stimulus. standing. REACTIONS

Upper and lower extremities Time lapsed between the presentation an body weight shift in of a visual (light) stimulus and the standing subject's response. This may be simple or require more complex choices (2, 4, or 8 choices for UE, 2 choices for LE).

MUSCLE TONE

Selected upper and lower Based on traditional manual methods, extremity body sites measures resistance to passive stretch (torque vs. angular position of limb segment) with a computer controlled, motor driven apparatus.

COORDINATION

Upper and lower extremity Measures coordination with protocol tests: similar to traditional finger to nose Reaching and tapping test (two targets). Result is a combination of speed and accuracy.

Tracking Measurements coordination by slow tracking of a randomly moving target. UE lateral, fore-aft, and two- dimensional modes are available.

STEADINESS

Body stability Based on the traditional kinesthetic awareness evaluations and the Romberg test, average lateral and fore-aft body sway (balance) is measured with an instrumented force platform during a timed trial. Tests are performed while standing on one or both legs, with eyes open and closed.

Hand/arm tremor Based on standard methods where

(resting and supported) assessment is made by observation, a special noncontacting sensor determines average vertical and horizontal tremor amplitude in millimeters.

MANUAL DEXTERITY

Gross and fine Based on computer-timed complex finger manipulation tasks, utilizing a Purdue pegboard and special* large _%peg apparatus.

ENDURANCE Based on performance degradation during longer duration trials of other tests.

ACTIVITIES OF DAILY LIVING

Putting on shirt The given ADL is computer-timed Zipping zipper Tying bow (shoelace) Button large button Button small button Manipulate safety pins Treading needle SIGNS Based on standard clinical procedures, certain key signs are observed by the technician and responses are entered.

TABLE 3

Relationship Between Function Catgories, Test Commands and Modes, Devices Used, and Measaures Obtained

MAJOR FUNCTION TEST PRIMARY RAW MEASURES OBTAINED

CATEGORY COMMAND MODEES . DEVECE(S) (STANDARD NAMES IN BOLDFACE)

MENTAL STATUS MEMORY Spatial Upper Extremity Number of items in a

ReactionTapping series correctly recalled

Board (timed sequencing): Short term memory, spatial

II Visual Video Graphics Short term memory, visual Display

II ATTENTION — Upper Extremity Precent correct responses

Reaction Tapping during 2 minute continuous

Board drill involving responses to randomly lighted targets: Attention

MS Computer Terminal Number of errors, corrected for educational level, in response to a standaradized, 10 item mental status questionnaire: General mental status

VISION VISION Eye Chart Percent central visual Computer Terminal efficiency:

Corrected vis. effic, R

Corrected vis. effic, L

AUDITION HEAR Low Freq. Headphones

SPEECH SPEECH Microphone Under.dev. SENSATION TOUCH 3 standard Touch/Pressure Length of filament body sites Aesthesiometer converted to pressure in dynesmm at sensory threshold: Touch, (site)

VIBS 2 standarad Sensory Console Vibration sense threshold body sites (Vibration in microns of vibration

Stimulato) Vibratory, (site)

TEMP Warm, Cool Sensory Console Therman sense threshold 2 standard (Thermal in degrees change from body sites Stimulator) baseline offset temperature during fixed heat transfer time interval: Heat, (site) Cold, (site)

TWOPT 2 standard Sensory Console Two point discrimination body sites (Two Point threshold in mm of stylus Stimulator) separation distance: Two-point discr., (site) OSIT 5 standard under development Position sense threshold body sites in degrees: Position, (site)

t V

MOTION Motion sense threshold in degrees/sec of velocity discrimination perception: Motion, (site)

ANTHROPOMETRIC FEATURES LENGTH 15 standard Biocurve Tracer Distance between two body pairs of body landmarks (pair selected sites from standarad menu) in millimeters: (site l)-(site 2) Exaπple

Unibillicus -M. Malleous

SFOLD Male/female Instrumented Skinfold thickness at sites Skinfold standard male and female

Calipers sites. Percent body fat is computed from standard regression equations: Body Fat

WEIGHT Force Platform Body weight in kilograms of force:

Weight

SPINE Biocurve Tracer Angles, in degrees, which characterize spinal curvatures:

Sagital xxx

RANGE OF MOTION ROM Biocurve Tracer Extremes of position (start stop) for limb segeimts for specific motion (e.g. flexi extension) about most body joints:

(site 1), (action)

Example elbow, extens.

SPEED SPEED Finger Upper Extremity Tapping speed in # taps per

Hand Reaction Tapping 10 sec:

Hand/arm Board Finger

Foot hand hand/arm foot

PS* Forearm Angular velocity in degrees/ ^■ Pronation/ sec, separately for pronatio

Supination Device and supination: Forearm, pronation forearm, supination

COORD* Upper Upper Extremity Average speed for lateral

Extremity Reaction Tapping movement between 2 fixed tar Board in cm sec:

_* lat. reach-tap, arm

_*

Lower Lower Extremity lat. reach-tap, foot

Extremity Reaction Tapping Board

MREACT* Upper Upper Extremity Average time to move hand

Extremity: Reaction/Tapping from one fixed target to

1 Choice Board another in milliseconds:

2 Choice . Arm Reach, 1 choice

4 Choice 2 choice

8 Choice 4 choice 8 choice

Lower Lower Extremity Average time to move foot

Extremity: Reaction Tapping from one fixed target to

1 Choice Board another in milliseconds:

2 Choice Leg Reach, 1 choice 2 choice

STEP* Upper Joystick, Video Joystick movement in degrees Extremity Graphics Display second: Lateral Supported arm sweep, lateral Fore-Aft Suported arm sweep, fore-aft

Lower Force Platform, Movement time in millisecond

Extremity Video Graphics Height shift, lateral

Lateral Display

REACTIONS SREACT Upper Upper Extremity Simple visual reaction time Extremity Reaction/Tapping milliseconds:

Board Hand/vsual, simple

II Lower Lower Extremity Foot visual, simple Extremity Reaction/Tapping Board

MREACT* Upper Upper Extremity Multiple choice visual react Extremity Reaction Tapping time in milliseconds:

1 Choice Board Hand visual, 1 choice

2 Choice handVisual, 2 choice 4 Choice hand/visual, 4 choice 8 Choice handVisual, 8 choice

II Lower Lower Extremity Foot visual, 1 choice Extrmity Reacticn Tapping foot visual, 2 choice

1 Choice Board

2 Choice

1

STEP* Upper Joystick, Video Hand-arm/reaction time to Extremity: Graphics Display visual stimulus in milliseco Lateral Arm sweep/vis., lateral Fore-aft arm sweepVis., fore-aft

•1 Lower Force Platform, Whole body (trunk) reaction

Extremity: Video Graphics time to visual stimulus in

Lateral Display milliseconds: Weight shift, lateral

STEP* Upper Joystick, Video Joystick movement in degrees

Extremity Graphics Display second:

Lateral Supported arm sweep, lateral

Fore-Aft Suported arm sweep, fore-aft

Lower Force Platform, Movement time in milliseconds:

Extremity Video Graphics Weight shift, lateral Lateral Display

REACTIONS SREACT Upper Upper Extremity Simple visual reaction time in Extremity Reaction Tapping milliseconds:

Board Hand/vsual, simple

II Lower Lower Extremity Poot/visual, simple Extremity Reaction Tapping

Board

MREACT* Upper Upper Extremity Multiple choice visual reactio Extremity Reaction Tapping time in milliseconds: 1 Choice Board HandVisual, 1 choice

2 Choice hand/visual, 2 choice

4 Choice hand/visual, 4 choice

8 Choice hand/visual, 8 choice

II Lower Lower Extremity Foot visual, 1 choice Extrmity Reaction Tapping foot visual, 2 choice

1 Choice Board

2 Choice

STEP* Upper Joystick, Video Hand-arm/reaction time to

Extremity: Graphics Display visual stimulus in millisecond

Lateral Arm sweep/vis., lateral

Fore-aft arm sweep is., fore-aft

II Lower Force Platform, Whole body (trunk) reaction

Extremity: Video Graphics time to visual stimulus in Lateral Display milliseconds: Weight shift, lateral

MUSCLE TONE RPM Elbow Elbow/Knee Resistance to passive motion. Driver FEature of torque vs. positio curves are extracted: (final decisions are

Knee Elbow/Knee under consideration)

Driver

Finger FingerWrist Driver

Ankle Ankle Driver

COORDINATION COORD* Upper Upper Extremity Index of performance in bits Extremity Reaction/Tapaping per sec:

Board Alt. lateral reach/tap, arm

Lower Lower Extremity Indes of performance in bits Extremity Reaction/Tapping per sec: " Board Alt. lateral reach/tap, leg

CRITIC Upper Joystick, Video Effective time delay of Extremity . Graphics Display neuromuscular loop in milliseconds: Progressiv tracking

RANDOM Upper Joystick, Video Joystick error, in degrees,

Extremity: Graphics Display from 20 sec trial of slow

Lateral _*• Arm random track, lateral

Fore-aft arm randon track, fore-aft arm random track, 2 dim. slow track coordination, ave

Whole Body: Force Platform, Error in position of center

Lateral Video Graphics of pressure on platform, per¬ Display cent of foot spacing distance Random weight shift, lateral

STEADINESS TREMOR Arm, Tremor Frame, Average movement amplitude,

Resting Video Graphics in mm, for 2 dimensions during

Arm Display (optional) timed trial:

Unsupported Arm resting tremor, horiz.

Head arm resting tremor, vert, arm sustention tremor, vert, arm sustention tremor, vert, head tremor, lateral head tremor, fore-aft

BODY BALANCE STABLE Eyes open: Force Platform, Average movement of lateral 1 leg Video Graphics and fore-aft center of pressur both legs Display (optional) while subject attempts to rema Eyes closed: still and balanced during time 1 leg trial. Measurre is converterd both legs to percent instability: Eyes open, lateral, 1 leg eyes open, fore-aft, 1 leg eyes open, lateral, both legs eyes open, fore-aft, both legs eyes closed, lateral, 1 leg eyes closed, fore-aft, 1 leg eyes closed, lateral, both leg eyes closed, fore-aft, both le

GAIT GAIT Video (under development) Robot ^•

MANUAL DEXTERITY DEXT Gross Upper Extremit Time required to executr Reaction Tapping specified manual task in Board, Large seconds, with timing error Pegboard removed:

Finger manipulation, gross

Fine Upper Extremity Time required to execute Reaction/Tapping specified manual task in Board, Purdue seconds, with timing error Pe board removed:

ENDURANCE -UNDER DEVELOPMENT¹

ACTIVITIES OF ADL 10 standard Uper Extremity Time required to execute DAILY LIVING tasks, Reaction Tapping specified ADL task in second easily Board, DL with timing error removed: expanded Accessories Putting on shirt to include zipping zipper others tying bow button large button button small button manip. safety pins threading needle stand up chair transfer walk 7 m

BASIC SIGNS SIGNS Smile, Computer Ordinal rating based on Tongue Terminal subjective observation of Pupils subject response to task requested:

Pupil symmetry ( nerve tongue deviation ( nerve) smile symmetry ( nerve)

II. System Components

A. Computerized Test Battery

The test battery represents the data acquisition component of the system. The basic philosophy behind design of the system includes the following points:

*The capability to measure a broad range of sensory and motor functions is essential.

*The battery must be applicable as a whole, or as selected subsets of tests.

*Scenarios used for tests of individual functions should resemble those used in traditional subjective ^• methods, as much as possible.

*A result for each test should be available that documents the level of a measured function. The result should be simple (ideally, a single number) and quantitative.

*Any part of the evaluation process subject to human error or opinion should be modified to achieve increased objectivity.

*Tests should be such that they can be administered by a trained technician.

The arrangement used to implement this philosophy is illustrated schematically in Figure 1.

The physical components of the test battery consist of a microcomputer system base unit (Digital Equipment Corporation LSI-11/23) and an interfact to modular peripheral test devices. Interface is achieved through a specially designed card cage, into which modules are inserted that interface individual transducers or stimu¬ lators. There are 7 different interface modules which can be used to interface 14 peripheral devices for administra¬ tion of various tests. Thus, a test battery can be fully configured or consist of only the modules required to implement the desired set of tests. In it's fully configured state, the battery is capable of acquiring nearly 500 different sensory and motor function measures.

A given test consists of a short duration scenario during which the subject responds to instructions giveii immediately prior to administration, and/or to stimuli presented during the scenario. Responses are measured by computer and used to compute the test result which is stored on floppy disk magnetic media (similar to those used in word processors). A separate disk is used for each subject. Complete details regarding data management suggestions are given below.

Tests are administered sequentially, as the subject moves through various test stations. Table 4 summarizes the general concept of the test battery. A list of major function categories for which one or more measurements can be made is presented in Table 5.

TABLE 4

GENERAL CONCEPT

TEST BATTERY

*SPECIAL SENSORS, STIMULI

*SHORT DURATION (5-60 sec) TASKS

*COMPUTER CONTROL AND RECORDING OF RESULTS *SOFTWARE TO "EXTRACT" KEY SINGLE NUMBER FEATURES WHICH CHARACTERIZE FUNCTIONS

*19 "MAJOR FUNCTION CATEGORIES" ACROSS MOST BODY SITES

*MORE THAN 500 MEASURES OF. FUNCTION

*APPLIED COMPREHENSIVELY, IN SUBGROUPS, OR SELECTIVELY

TEST RESULTS: "RAW MEASUREMENTS (Kilograms, Msec. N-M, Degrees, etc.)

TABLE 5 MAJOR FUNCTION CATEGORIES

*MENTAL STATUS ^♦REACTIONS

^♦VISION ^♦COORDINATION

*AUDITION ^♦STEADINESS

*SPEECH ^♦BODY BALANCE

^♦SENSATION ^♦MUSCLE TONE *ANTHROPOMETRIC FEATURES ^♦MANUAL DEXTERITY ^♦RANGE OF MOTION ^♦GAIT ^♦STRENGTH ^♦ADL

^♦SPEED ^♦ENDURANCE

B. Hardware Components

A Digital Equipment Corporation (DEC) LSI-11/2 minicomputer, housed in a Charles River Data Systems (CDS) MF-211 package, forms the core of the system as it is presently employed. The MF-211 contains 32K words of resident memory, 1 single-sided floppy disk drives for permanent storage, power supplies for the MF-211, and modules including a 16-channel analog-to-digital converter (A/D), 2-channel digital-to-analog converter (D/A) and display driver (all on Data Translation DT-1761 module), real time clock (Data Translation DT-1769), serial data input/output interface (DEC DLV-11J) , and a 16-bit parallel data input/output interface (DEC-DRV-11) . These modules provide the interface between the computer and support hardware for specific tests.

_* * \

The MF-211 is mounted in a specially designed and constructed console along with a modified Wavetek Model 1951 X-Y display (30 cm diagonal screen) to present stimuli during tracking tests and for other purposes requiring visual output. A 10-slot card cage containing interface and support hardware for test stimulators and transducers and a multi-output power supply are also housed in the console. Reserve space is allocated in the card case and the power supply is overrated to accommodate expansions. An auxiliary analog I/O panel provides the facility to connect electrophysiologic amplifiers for implementation of evoked potentials and related electro- physiologic tests.

A computer-addressable audio cassette system represents a unique feature included in the console. Utilizing a Triple-I Model 0EM-1A2 stereo cassette deck, any portion of a cassette tape can be addressed and located quickly and accurately by manual keypad or auto- matic computer instruction. After the technician selects the desired test, a programmed sequence retrieves the corresponding tape address from a look-up table then locates and plays pre-recorded instructions for the patient to carry out the task. Each instruction is terminated with a 250 ms tone burst which is decoded by the controller to halt the cassette. Instructions may be repeated as necessary by pressing a key (REPEAT) that reloads the search address and initiates playback after locating it. Features for recording tapes with the appropriate format and obtaining search addresses for programming purposes are included. In addition to the benefits of increased objectivity and repeatability in administering test instructions, the tape facility is an important step towards total automation of future systems which may include an audio-visual instruction system with format and features .similar to the audio system described here.

Other system components include a video terminal, a line printer for result output, a plotter for graphical results from certain tests, and two tables that match the main console. Various tests or stations, with appropriate stimulators and transducers, are assigned to specific sites on these tables to minimize test set-up and conse¬ quently total testing time. Human engineering factors including color selections, were taken into account during system design. We utilized black table tops and console, along with a smoke plexiglass console panel to provide maximum contrast to visual stimuli. Blue trim was added to provide a relaxing effect intended to reduce patient anxiety. Figure 1 summarizes system components and their interconnections.

The above described systems hardware is illustrative of a preferred embodiment and those of skill in the art will recognize that other hardware systems may be incor¬ porated to achieve the advantages of the present invention without departing from its intended scope.

C. Sensory and Motor Function Data Base

The data base is designed to provide immediate access to information in various formats, as well as organized storage of sensory and motor function data. In order to evaluate a patient's sensory and motor function on the basis of measurements collected with the computerized test battery, there is an associated need to establish standardized and simplified methods of interpretation. With the present system, functions are measured in physical units (milliseconds, kilograms, bits per second, etc..) that are appropriate to describe and quantitative the- given function. Difficulty is encountered when a clinician is presented with a printout of these so called "raw test results" and is expected to interpret them. The difficulties arise from several factors:

^♦There may be more than several hundred measures of function on a single printout;

^♦Raw test results contain many different physical units (msec, kg, microns, newton-meter, etc.) to comprehend;

^AIn order to identify positive and negative findings, the clinician must have some knowledge of normal results for each different test;

^♦Normal function changes with age and is different for males and females, and thus normal results must be mentally adjusted by the clinician to take into account the subject's. age and gender.

These factors make meaningful interpretation of raw test results essentially impossible by all but those clinicians that are intimately familiar with the test battery. Therefore, in order to put the system into wider clinical use and to facilitate research, it was necessary to develop an approach that would allow clinicians to assess a patient objectively, accurately, and easily.

This system is intended to relieve the clinician's burden of memorizing a host of normal test result values and present results in a form that is immediately inter- pretable. Thus, it is emphasized that the prime purpose of the data base system is to facilitate interpretation of test results and to simplify conduction of systematic studies^"based on the ^"data base,^" as opposed to mere mass storage of data. .

Two sensory and motor function systems are currently in operation in Dallas, at the University of Texas Health Science Center at Dallas and the Dallas Rehabilitation Institute. In addition, the original prototype of the system is located at the Wadsworth Veterans Administration Medical Center, Los Angeles. Under a Cooperative Research Program, replicas of the test battery have been placed at several remote sites. Therefore, it is desirable for the system to have the capability of receiving patient data from remote locations, such as clinicians' offices, as required. The arrangement used is illustrated in Figure 2.

The Sensory and Motor Function Database Management System as presently employed, spans several computers at different sites. Data collection and some report printing are performed on LSI-11/23 computers at Sensory and Motor Function Test Laboratories. The central research database is maintained on a VAX 11/780 computer at The University of Texas at Arlington. The central database can be accessed by telephone from any site equipped with a terminal, modem, and telephone. The Database Management System includes utilities to transfer date from the LSI-11 computers to the VAX computer, and to allow the LSI-11 to be used as a terminal to the VAX.

It is important to note that individual data records stored in the database normally may be accessed only by personnel from the office and the data collection site where the subject was tested. All users have access to the statistical profiles that describe the database as a whole, but not to information in data records from other data collection sites. This feature is merely a coifiden- tiality consideration, and is not a- requisite, for a basic ^'realization of the system.

Figure 3 presents a description of the flow of information in the database system. Note that the programs and files referred to in Figure 3, have been given symbolic names for simplicity. These names are used for general discussions of the database system. There programs will be referred to by their system name in following sections which deal with their function in more specific terms.

C. Software for Test Result Compression and Reporting

A software package has been developed to allow data management and test result reporting. Minimum test result reporting can be accomplished with the LSI-11 in the clinic, independent of the VAX central data base. More complete reports of various formats can be obtained by direct interaction with the VAX, which requires that test results be transferred to the central data base. Patients motorsensory function data is indexed in the central data base in terms of both objective and subjective diagnostic evaluations. Thus, when a "test" patient's raw or formatted function parameters are compared against stored function parameters in the central data base, the prior diagnostic evaluation of previous patients exhibiting similar parameters will serve as a basis for diagnosti- cally evaluating the "test" patient. Accordingly, as more and more individual patient data is indexed into the central data base, the more accurate the central data base becomes as a diagnostic tool.

Among the programs that run on the LSI-11:

-Program "D" is used to read the various test data files from a test subject's floppy disk and produce integrated fixed-format data records (no printout) that include all results from a particular test session. These integrated data records may be passed on to the database on the VAX.

-Program "P" will produce "raw data" print-outs containing all measurement values taken during one test session.

-Program "L" is used to combine the integrated data records from several patient disks onto one disk. The disk with several patients can then be stored as an archive or mailed to the Center for Advanced Rehabilitation Engineering (CARE) for the data to be added to the database. -Program "R" is a limited version of the VAX-based retrieval and reporting program of the same name. It can be used to display data and to print reports in which the primary format is a comparison of test subject data to characteristics of normal popula¬ tions. An example of a typical test report, which can be obtained on the LSI-11, a comparision of results to a selected population, (standard report), is shown in Figure 4.

-Program "X" is used to transfer data to the VAX computer.

-Program "T" allows the LSI-11 to be used as a terminal for communicating with the VAX.

e VAX ^"computer: .

-Program "C" reads the data records transferred to the VAX with Program "X" and adds them to the Sensory and Motor Function Database.

-Program "R" is the primary retrieval and reporting program. It can display or print individual records, summaries of groups of records, and popula¬ tion statistics. This program is the "heart" of the Sensory and Motor Function Database Management System. Figure 5 illustrates a composite report, which is representative of the reporting variety available on the VAX based Program R. -Program "E" is the database editor. It can modify any data in any record in the database.

III. Technical Description of Individual Tests

This section contains a detailed description of each test, organized by measures obtained under major function categories. The device(s) used and measures obtained are listed. Note that a "TEST" is operationally defined as a specific task which a subject is asked to carry out. In many cases, there is a one-to-one correspondence between a given "test" and a given measure. However, sometimes during a given "test" additional measures (which may fall under other major function categories) are obtained. For example, during a single forearm pronation/supination "test", speed and active range of motion measures are- obtained. Such cases are clearly pointed out.

For some major function categories such as ISOMETRIC STRENGTH, a large number of individual tests exist. This is associated with the present system configuration. The general data acquisition and signal processing procedures used across all sites is essentially the same and there- fore, is only described once. In those cases, body site selection is usually menu oriented. Selection of a given body site may imply use of a specific device. Factors such as these are detailed where appropriate.

1. Mental Status

This category currently includes two separate tests and is expected to expand. The two separate tests are: a. Short-term memory b. General mental status

A separate measure is obtained for each as described below.

a. Short-term memory

Devise used: Upper extremity reaction tapping board (spatial mode), or video graphics display (visual mod)

Short-term memory: A common test was adopted which is normally administered verbally (reference). The test has two modes: spatical and visual, similar to the populajr electroning game "Simon".

In the spatial mode, the test is conducted with- the upper extremity reaction/tapping board. The patient is presented a sequence of LED stimuli, beginning with a sequence length of 1 and increasing by 1 after successful trials. Following each sequence, the patient reiterates the pattern by touching target sensors corresponding to the LED arrays that formed the sequence. Each LED array is turned on for 2s with a 1-s delay between lights. The test is terminated when the patient makes an error or delays longer than 10s during the response period. The length of the longest sequence the patient is ..capable of repeating serves as the test measure, with a sequence consisting of ten elements as a maximum.

In the visual mode, the video graphics display is used to present a series of random numbers (1 to 8). - After the timed sequence is presented (same timing para- ^' meters as for spatial mode), the numerical sequence is displayed for viewing by the technician. The test subject is prompted by the video graphics display at the end of a given sequence to repeat the sequence verbally. The technician listens to the response and verifies it against the displayed string of digits for correctness of order. Any error or long delay terminates the test.

b. Attention span

Device used: Upper extremity reaction/tapping board

This test provides a challenge to the attention span of the test subject. At random intervals (1-6 seconds from test start or last response), a randomly selected LED array (1 of 8) turns on for 1 second. The subject is required to visually monitor the board constantly and make appropriate response (touch the plate in front of the select light) in a timely fashion (within 3 seconds after the LED is turned on). If the patient does not respond within this period, the response is considered as incorrect. The percentage of correct responses over a 2 minute test duration is recorded as the test score.

c. General mental status

Device used: Computer terminal

A standardized 10 item general mental status questionnaire is administered. Test questions are preprogrammed so they are displayed on the computer terminal, one at a time, to be viewed by the test adminis¬ trator who then asks the subject the appropriate question. The subject responds and the technician judges whether the subject responds correctly or incorrectly. A list of the ten questions appears in Table 6. TABLE 6

The Mental Status Questionnaire (MSQ) Used for General Mental Status Test

1. What is this place?

2. Where is this place located?

3. What day in the month is it today? 4. What day of the week is it?

5. What year is it?

6. How old are you

7. When is your birthday?

8. In what year were you born? 9. What is the name of the president?

10. Who was the president before this one?

Score shows severity of brain syndrome:

0-2 errors = none or minimal 3-8 errors = moderate 9-10 errors = severe

2. Vision:

A standard Snellen-Jaeger eye chart (20 foot literate, manufactured by Graham-Field) is used to deter- mine corrected distance vision (with glasses if the subject normally wears them) . Software is provided to allow the technician to enter the chart line number corresponding to the smallest letters the subject can read, which is then converted to visual acuity and then to a score of percent central visual efficiency. Table 7 indicates the conversion factors used. The conversion process takes into account the fact that the chart is used with a subject to chart distance of 15 feet, instead of 20 feet. TABLE 7

Conversion Table and Equations for Snellen Eye Chart Line Number to Percent Visual Efficiency

Chart Corresponding visual line number acuity angle (minutes)

1 10, .00 2 5, .00 3 3, .50 4 2, .50 5 2, .00 6 1. .50 7 1. .25 8 1. ,00 9 0, ,80 10 0. ,80^A 11 0, ,80^Λ

^♦Saturation at 100% visual efficiency

For Chart Line Equation Used Line j£ For Percent Visual

Efficiency (PVE)

1 PVE = Acuity (1) + 30 2,3 PVE .= -7.59^ΛAcuity ( ) +89.29

4-7 PVE = -15.9^Acuity ( ) +115.9 8-11 PVE = 100

3. Audition

Unilateral and/orbilateral tests are conducted with the test subject wearing headphones (Telephonies TDH-39). Representative low (1 KHz) an high (5 KHz) range assess- ments are available with programmable audio amplitudes ranging from 14 dB (Sound Power Level - SPL) to 80 dB(SPL) in 3.0 dB increments. The test subjects' auditory thres¬ hold is expressed in decibels (dB SPL). The standard

2 reference of 0.0002 dynes/cm (or ubars) is used to correspond to 0 dB SPL. The two-alternative forced-choice test method is described in greater detail in Section III. 5.a below.

A test is composed of several trials presenting auditory stimulation of varying amplitudes to determine a test subject's auditory threshold at the preselected frequency. Each trial consists of:

1) a "START" prompt (t = 0.75 sec.) 2) an active interval (t = 4.5 sec.)

3) A NULL INTERVAL (t = 3.5 sec.) and

4) a "wait for subject response" period (no defined time duration)

During the null interval, no auditory stimulation is presented to the test subject. The active (stimulus) interval consists of a sinusoidal stimulus rising in amplitude exponentially (t = 0.54 sec.) to a predetermined amplitude (stimulus level). After remaining at this level for 2 seconds, the level (amplitude) is decreased to zero exponentially (t = 0.75 sec). The amplitude envelope is intended to prevent false interpretations of step pressure waves as tone stimuli. As with other sensory tests using the two-alternative forced-choice method, 22 stimulus levels are employed (Refer to Table 8 for documentation of levels used) .

A typical test proceeds as follows. After entry of the test command, the computer generates a series of prompts and questions for the clinician to determine the specific test and its parameters. The following demon¬ strates the initial prompts, questions, sample responses (underlined) and comments: Terminal Display Comments

IHEAR -select audition test

HEARING FREQUENCY 1 = 1 KHz

5 = 5 KHz

-test at 1 KHz

TYPE Y FOR READY -begin test

Z FOR CAN'T DO -select another test

M FOR MODIFY PARAMETER -allows choice of

1 KHz or 5 KHZ again in case of error

At this point the test begins. The video graphics, display displays the "START" message prior to the two stimulus intervals forming a trial. The first interval is announced with display of "INTERVAL 1" and the second interval is announced similarly with "INTERVAL 2". At the conclusion of the second interval, the monitor screen displays the prompt "ANSWER - ?". At this point the test subject responds "one" or "two" to indicate the interval during which the stimulus was perceived. The test admin¬ istration receives a similar prompt from the terminal screen to enter the test subjects response. For example:

Terminal Display Comment

RESPONSE (1, 2, or K (= Kill))? -signifies test 2 subjects choice of active interval

A response of "K" would have terminated the test. When a response of "1" or "2" is entered, the test will proceed with another trial as above until the termination criteria of the two-alternative forced method are ^' achieved.

At the conclusion of the test the auditory threshold at the preselected frequency is displayed via the terminal.

Example:

Hearing Test Result in db(spl): Mode Maximum Minimum Average L 45. 42. 44.

TABLE 8 Stimulus Levels used in Audition Test

Level db gPL

5

1 0

2 6

3 12

4 15 10 5 18

6 21

7 24

8 27

9 30 15 10 33

11 36

12 39

13 42

14 45 20 15 48

16 51

17 54

18 -57, .

19 60' 25 20 63

21 66

22 72

4. Speech

a. Introduction: General Methods

The objective of the Speech Test Battery is to evaluate the functional integrity of the human speech production system. Speech is the acoustical product of programmed movements of the respiratory and masticatory apparatus. Energized by the thoracic and abdominal musculature, air is exhaled from the lungs through the trachea into the pharynx. The larynx houses the vocal cords and vibrations of the vocal cords generate the initial sounds of speech. Then, the acoustic waves, thus produced, are modulated by the movements of the articu- lators (lips, jaw, tongue, velum) to create speech patterns. Therefore, different movements of the articu- lators result in production of .different sounds. In general, speech production is a phenomenon involving . neurophysiological, linguistic, respiratory, phonatory, articulatory, and auditory systems.

The speech test instrumentation consists of a micro¬ phone, amplifier, filter, frequency to voltage converter, and the system data acquisition components and computer. This hardware generates several different waveforms for subsequent digital signal processing.

Speech tests consist of computerized, short-duration procedures developed to quantitate speech motor function for assessment of rehabilitation progress and diagnosis. A set of carefully selected speech tasks is used to isolate phonatory-respiratory, palatopharyngeal, and individual components of articulatory subsystems of the speech production mechanism independently as well as in simultaneous and coordinated functioning. Operationally, while the subject performs the task, the acoustic signal produced is filtered, digitized, and processed in time- domain to extract features which characterize specific speech functions.

The comprehensive speech test battery consists of 17 specific tests (see the master list) organized in 7 easily accessible modules. Modules are selected from a menu which is presented after the SPEECH command is entered. A master list of basic speech tests is shown in Table 9. Table 10 represents the primary speech module menu.

TABLE 9

Speech Test Master List

1. Vocal reaction time

2. Phonatory strength

3. Shimmer and jitter

4. Diadochokinetic rate 5. Phonational frequency register

6. Pneumolaryngeal strength range

7. Bilabial function

8. Bilabial-vocal cords function

9. Labiodental function 10. Labiodental-vocal cords function

11. Lingua-dental function

12. Lingua-velar function

13. Lingua-velar-vocal cords function

14. Lingua-palatal-vocal cords function 15. Lingua-alveolar function

16. Lingua-alveolar-vocal cords function

17. • Glottal function

TABLE 10

Primary Menu for Selection of Speech Test Modules

1. Pneumolaryngeal interaction

2. Phonatory localization

3. Vocal synoptical function

4. Laryngeal quality 5. Phonational frequency register

6. Speech quality

7. Overall speech profile

b. Voice reaction time

This test measures the voice onset time (reaction time) in milliseconds. Program control returns back to the module menu upon completion. During the reaction time test, brief test instructions are first displayed. After the operator enters the "ready" signal, a short audio tone is produced to prompt the subject to begin phonating the required vocal task. A similar tone will declare the end of the test.

Processing consists of a simple routine which waits for the "ready" signal from the operator, and then produces a §§beep!l to declare the start of the test. At the same time, a real-time clock is started with an interrupt rate of 10 KHz. At each interrupt the output of the A/D converter (i.e. digitized value of the filtered, and rectified and amplified output of the microphone, or speech envelope) is checked and compared with a preset threshold, determined according to the normal background noise in the test environment. If the envelope amplitude is above the threshold, then the clock is stopped and the time counter (interrupt counter) contains the voice onset time (reaction time) of the subject.

c. Phonatory strength

The phonatory strength subroutine measures the average loudness (db) and the maximum time a subject can sustain a single phonation. When the routine is called first the test instructions are displayed and then the routine awaits the "ready" signal from the operator. Then, a tone is generated to mark the beginning of the test. Test termination is automatically determined (as described below) and signaled with a second tone. Upon completion, program control is returned to the main menu.

Processing for the phonatory strength test calls on a routine which first displays the test instructions and then waits for the "ready" signal from the operator. After the start tone the real-time clock is initiated with an interrupt rate of 100 Hz. First, the value of the digitized speech envelope is compared with the preset threshold (set according to test environment background noise level). When the speech envelope exceeds the threshold (as the subject begins the task), a counter is incremented for each interrupt occurring past this time. During each interrupt (every 10 msec), the speech envelope is compared with the threshold. If above it, the partial area under the speech envelope is calculated and added to an accumulating variable, AREA. And also the counter is incremented. If the speech envelope drops * below the threshold for at lea^'st 2.6 seconds (experiment- ally determined), the test is terminated. The end of the test tone is then issued. The counter provides the prolongation time. The total area accumulated, divided by the prolongation time, provides a measure of average loudness in dB SPL.

d. Shimmer and jitter

The shimmer/jitter test measures the cycle-to-cycle variations in amplitude and period (frequency) of the raw speech signal. Upon selection of a module which incor¬ porates this test, brief test instructions are first displayed and the computer awaits the "ready" signal from the operator. Test duration is times to be 5 seconds. The start and end are declared by short tones. For processing, raw speech is digitized at a rate of 6.66 Hz. Zero-crossing measurement is employed to identify each period. The zero-crossing of the raw speech acoustical wave is calculated in an anticipatory manner 5 i.e. at each apparent zero-crossing the sample values for the next 0.6 msec are checked and if no sign change occurs, then that point is accepted as a zero-crossing.

Shimmer is calculated as the average sample standard 10 deviation of peak amplitude of every 7 consecutive periods (of the acoustic wave) for 1 sec (the 3rd second of the task). Thus, the units are dB SPL. Total jitter is evaluated as the average jitter of every 7 consecutive periods, as for shimmer. Jitter is calculated as the 15 sample standard deviation of periods divided by average period in percent.

e. Diadochokinetic rate

20.

The diadochokinetic rate is a measure of repetition of rapid, alternating syllables requiring the performance of different articulators. Upon execution of this routine, first the test instructions are displayed and 25 then after the "ready" signal is given by the operator, processing begins.

Processing relies on a routine which digitizes the speech envelope (100 HZ) rate) and uses these values to 30 calculate the average and peak strength, syllable interval, speed, and intersyllable duration for the task syllables uttered during the test duration.

The real-time clock is initialized to produce an 35 interrupt rate of 100 Hz (10 msec interrupt period) and a tone is generated to mark the beginning of the test. At each interrupt (following detection of speech onset), the speech envelope is compared with the subject's speech threshold, if higher, a counter THIGH is incremented and the partial area under the envelope is added to the total area location AREA (as explained for the PS-subroutine). Furthermore, the envelope value is compared with the value of variable PEAK, which is replaced with the new value if it is larger. Otherwise (when the envelope value is less than the threshold) a different counter, TLOW, is incremented. If TLOW becomes larger than 70 msec a syllable is considered complete. Otherwise, TLOW is added to THIGH and the program continues. When a syllable is completed, THIGH gives the syllable duration, PEAK the syllable peak intensity (amplitude), and AREA over THIGH lends the average amplitude. At the onset of the next syllable, TLOW provides the intersyllable interval. At this point, calculated values are saved and the counters are reset,. Another counter', NO, is incremented to count the number of syllables. The test is automatically terminated after 5 seconds with a tone.

f. Phonatory frequency register

This module determines the fundamental and the first 3 formant frequencies, as well as their variations. First, the test instructions are displayed and then after the "ready" signal from the operator, the FR-subroutine is called. The routine provides a short tone for start and end of the test which lasts 5 seconds. Results are saved and program control returns to the module menu. g. Pneumolaryngeal strength dynamic range

This test measures the maximum and minimum of voice intensity (loudness) in dB while the subject attempts to sustain a fixed voice fundamental frequency.

First, test instructions are displayed on the screen and after the "ready" code is entered by the operator, a brief tone is generated to prompt the subject to start the task. Results are saved and program control returns to the module menu upon completion of the test.

During processing the real-time clock is initialized to produce an interrupt rate of 100 Hz, which also deter- mines the digitization rate for the speech envelope. At first, at each interrupt the value of the digitized speech envelope is compared with a preset threshold (determined with consideration of the background noise level) and wheϊi the speech envelope begins to rise above the threshold, the first value is stored in the variables MIN and MAX.

For each interrupt following the first threshold crossing, the envelope value is compared with MAX and used to replace it if larger and processing continues. Otherwise (if envelope value is less than the current value stored in MAX) , the new value is compared with the MIN and replaces it if smaller. This cycle repeats every 10 msec for the 5 second test duration. At the end, a tone is generated. Minimum and maximum values in dB SPL are retained as measures. The test time is controlled by a timer started at the first threshold crossing.

h. Phonatory localization tests

A set of 11 similar tests for evaluation of various components of the vocal tract system are grouped under the general category of phonatory localization tests. The options available are:

1. bilabial

5 2. bilabial-vocal cords

3. labiodental

4. labiodental-vocal cords

5. linguadental

6. lingua-velar

10 7. lingua-velar vocal cords

8. lingua-palatal-vocal cords

9. lingua-alveolar

10. lingua-alveolar-vocal cords

11. glottal

15

The primary difference is the choice of speech task which is used to isolate a given anatomical site. The operator can choose any of the phonemic localization tests by entering the respective command. The command prompts

^■20 the routine to display the instructions for ^'the specific test selected. Then, the program waits for the "ready" signal from the operator. The start and the end of the test are declared by short audio tones. Each test duration is 5 seconds and measures obtained are: average

25 and peak strength (dB), and duration (msec) for each syllable, and speed (syllable/sec), intersyllable intervals (msec), and number if syllables for the task performed. The results are saved and program control returns to the module menu.

30

Execution of the tests in this group requires establishment of a specific acoustic intensity threshold for each subject to allow automated control and measure¬ ment of features of the task performed. Therefore, first

35 and routine for calculation of the subject's unique threshold is called and executed. This value is saved and used for other tests. Threshold determination is actually a short version of the phonatory strength test in the module. After instructions are displayed, the "ready" signal is issued by the test administrator. A short audio tone prompts the subject to start the threshold task. The operator then enters his/her appropriate threshold coefficient and then the program control returns to selected localization test.

Processing is essentially the same as for the phonatory strength test, except that after the average intensity is found, the result is displayed on the screen and the operator is asked to determine the percentage of the mean amplitude to be used as threshold. Then, the threshold is calculated and stored.

5. Sensation

> a. General test methods

The Sensory Test Battery currently consists of tests for four separate modulaties: 1) Touch/Pressure, 2) Vibration, 3) Thermal Discrimination, and 4) Two-Point Discrimination. Each test employs the same basic methodology: the two-alternative forced choice method.

With the two-alternative forced choice method, each test consists of a series of trials to determine a subject's sensory sensitivity (commonly called a sensory threshold). Each trial consists of a pair of sequential intervals and an end-of-trial signal (monitor display and/or tone). Each interval begins with a warning signal that prompts the patient to pay close attention. A stimulus of known intensity is presented in only one of the two intervals. At the end of the trial the patient responds "one" or "two" to indicate the interval during which the stimulus was perceived. These verbal responses serve as inputs to a computer algorithm that implements the methodology, and decisions are made automatically to either present a stimulus during the first or second interval of the next pair (random with equiprobable distribution), increase or decrease stimulus level for the next trial (according to rules described below), and determine when to end the test. A schematic representa¬ tion of the two-alternative forced choice method is displayed in Figure 6.

For each modality, stimulus intensities are divided into 22 levels, with finer gradation near normal thres¬ holds. Stimulation begins at level 11, specifically assigned to be significantly above the minimum detectable by normal subjects. Two incorrect responses in a row cause a jump to level 16, whereas~two correct responses move the stim lus level to 6. From these points, -a maximum of four stimulus intervals is presented at any given level. Scoring 75 percent correct responses causes a decrease by two stimulus levels. Any response sequence precluding a 75 percent correct rate in four trials causes an increase by two stimulus levels. This continues until a direction change occurs. Stimulus levels are then changed by 1. Following the third direction change, the test is terminated and the threshold is determined as the average of the stimulus levels where the last two direction changes occured. The use of the same method for all sensory tests requires the patient to be familiar with only one algorithm. During sensory tests, room lights are dimmed and limitation of extraneous noise is encouraged to allow total patient concentration.

b. Vibration, thermal, and two point discrimination senses Vibration, thermal, and two point discrimination test instruments are contained in a small console. Stimulators protrude through cutouts in the console's sloping front panel. The console may be placed either on a table for testing upper extremity sensation or on the floor for lower extremity tests. Center areas of the palmar and plantar surfaces of the hand and foot, respectively, are placed over the appropriate panel cutout to serve as test sites.

The vibrometer combines the separately applied features of previous devices. A galvanometer (MFE Corporation Model R4-160VSS), used to drive a stylus sinusoidally (200 Hz), is mounted on an adjustable counter-balanced lever beneath the panel to allow stylus- skin contact force regulation (set at -20 g). The velocity of the 2-mm diameter flat-faced stylus, transduced by a separate coil in the galvanometer, is proportional to the displacement amplitude when frequency remains constant and serves as feedback which is rectified and low-pass filtered at 10 Hz to provide constant displacement amplitudes, even if the load changes. During the interval containing the stimulus, the desired level is approached exponentially over a 3-s interval, maintained for 1 s, and then decreased exponentially. This limits interpretation of stimulus presence as an abrupt force increase rather than vibration. An inter-interval delay of 5 s prevents receptor adaption from becoming a significant factor.

Thermal stimuli have been produced with pumped-fluid ther odes, metals with different heat conduction properties, and solid-state thermoelectric units. We chose to us the latter device since it is most adaptable to computer control and provides good results clinically. A thermoelectric heat pump (Marlow Industries, Model

MI 1022-02), mounted to a heat sink with thermally conductive epoxy, provides both warm and cool stimuli.

The unit is mounted coaxially in a hollow aluminum tube that is attached perpendicularly beneath the console panel, with the surface of the heat pump/heat sink assembly protruding 1 cm. When a test site is placed over

2 the 0.65-cm heat pump area, spring loading maintains a constant but comfortable skin pump area, spring loading maintains a constant but comfortable skin contact. A thermistor is used to sense when the pump's skin contact side has equilibrated to hand or foot temperature. At this time, a small temperature offset (+2 C-warm sensation, -2 C-cool sensation) is generated and controlled by the termistor feedback. During the stimulus interval, an additional offset (amount determined by stimulus level) is presented for 3 s .after equilibrium is reached. Temperature is then returned to the preinterval level. The temperature remains at the small offset level during the other interval. The patient responds "one" or "two" to identify the interval during which a temperature change was perceived. The minimum temperature change perceived (in degrees centigrade) is determined after a sequence of such trials.

Two point discrimination has long been assessed with hand-held calipers. In this instrumented test, the test site is positioned over a 7-cm panel slot. Beneath the panel, two motor driven styli, with feedback control of stylus position, are mounted on a track. The separation of the styli about a central focus point is adjusted by stepping motors. When a given drive motor is actuated by applying a position profile control voltage, the stylus it drives strikes the test site perpendicularly for 1 s. Solenoids and separation are controlled by the computer. One or both stylus drive motors are activated in random order during each trial. The position profile control voltage changes over time to produce the desired approach velocity. The test proceeds until the minimum perceptible separation (in millimeters) is determined.

c Touch/pressure sense

Since the elaborate methods devised for quantifying touch sensation are time consuming and difficult to replicate for routine use, a simple, old technique which has sufficient resolution and reliability for clinical assessment has been instrumented.

The technician conducts the test by applying a calibrated nylon filament (Cochet-Bonnet aesthesiometer replacement filament) contained in a hand-held aesthesio- meter, perpendicular to the testing site until bowing occurs. When applied in this manner, the length of the filament is inversely proportional to pressure at the tip of the filament. Hairless areas are tested to avoid the lever action from touched hairs. Patient responses of "one" or "two" are entered via push-buttons on the aesthesiometer after each trial, at which time the computer algorithm decides to either stimulate or not during the first interval of the next trial, informing the technician of the decision via the graphics display, and to either increase or decrease the length of the filament by actuating a motor-driven rotary-to-linear motion translator with position feedback contained within the stimulator. The filament length at the end of the test is converted to corresponding pressure with a programmed calibration curve supplied with th filament. 6. Anthropometric Features: Lengths and distances

Devices used: Biocurve Tracer

Lengths of body segments are measured with the biocurve tracer, a device capable of measuring the coordinates (x,y,z) of a point in space accurately over the volume large enough to allow measurement of a human figure.^' Each measurement consists of a sequence of two point measurements. All points used in the development protocol are standard body landmarks. First, the coordinates of one point are determined and then the coordinates of the second point. A computer algorithm, using simple vector algebra techniques, uses the pair of coordinates to compute the straight line distance between the two points in millimeters.

A menu driven approach is used for test administra¬ tion (refer to Table 11. The test administrator first selects the desired site option. The video graphics display then prompts the test administrator to an appro¬ priate body landmark. "Smart" software is employed to follow movement of the Biocurve Tracer tip. When the administrator has placed the tip at the landmark and holds it relatively stable for approximately 0.5 seconds, the coordinates will automatically be digitized. An audible "beep" is issued to verify that this has occurred and the technician is then prompted to the second of the pair of landmarks associated with the measurement selected. The coordinates of this point are then digitized and the measurement result is displayed as follows:

Length: (site 1) - (site 2) = xxx mm TABLE 11

Length Measurement: Menu driven test administration and site selection options

Menu A Result of Specific Selection General Site Options

1 - Height Prompt technician to proper sites (2) for height measurement

2 - Spinal Prompt technician to proper sites (2) for spinal measurements

3 - Upper Extremity Asks "Body Side (R or L)?" and

Displays Menu B

4 - Lower Extremity Asks "Body Side (R or L)?" and

Displays Menu C

Msnu B

Upper Extremity Segment Options

0 - All . Automatically cycles through options

1 - Acrom.-Middle Finger 1-4

2 - Acrm.-Elbow Technician is prompted to digitize

3 - Olecrenon- coordinates of the two landmarks

U. Styl. Proc. listed for the selected option

4 - U. Styl. Proc.

Middle Finger

Menu C

0 - All Automatically cycles through options

1 - Umbil.-m. malleolus 1-9

2 - ASIS-m. malleolus

3 - Urribil.-floor

4 - ASIS-floor Technician is prompted to digitize

5 - ASIS-knee coordinates of the two landmarks

6 - Ischium-knee listed for the selected option

7 - Khee-m. malleolus

8 - Tibial tub.- m. malleolus

9 - Heel-longest toe 7. Range of Motion

Range of Motion measurements with the biocurve tracer, a device capable of measuring the coordinates (x,y,z) of a point in space, fall into two categories: four-point measurements and eight-point measurements. Four-points are used for range of motion measurements of upper and lower extremitites (except for fingers and toes) while eight-points are used for range of motion measure- ments in the cervical and lumbar regions of the spine.

The biocurve tracer is mounted to one of the system's tabletops. Its x-axis arid y-axis are perpendicular and parallel to the edge of the table, respectively. The z- axis is perpendicular to the tabletop. The xy-plane is in parallel to the table top, the yz-plane runs through the edge ^'of the plane and is perpendicular to the xy-plarϊe, and the zx-plane is perpendicular ^"to the other two planes. The proper mounting of the biocurve tracer and the orientation of its cartesian xyz-axes are important, because all range of motion measurements are referenced to these three cartesian planes. Planes and terms usually used for describing parts in and on the human body are shown in Figure 2-20.

Once the general test category is selected, range of motion tests are menu driven. The computer prompts the operator to advance from general anatomical areas like upper extremities or lumbar spine to specific anatomical sites. These sites, and the menu tree structure are illustrated in Table 12. Short and succinct instructions are issued to the operator.

Table 13 represents a master list of test sites, anatomical landmarks, special instructions, reference planes and reference angles. After four or eight points have been measured, the computer will calculate range of motion data and store the data in an appropriate file. It is emphasized that the subject must be positioned properly with respect to the xyz coordinates of the biocurve tracer and that the sequence of measuring points must not be changed; i.e. landmark A is always measured first, then landmark B, etc.

TABLE 12

RANGE OF MOTION: MENU DRIVEN TEST ADMINISTRATION AND SITE SELECTION

Menu A Result of Specific Selection General Site Options

1 - Cervical Spine Display Menu B

2 - Lumbar Spine 3! - Scapula Ask "Body Side (R or L)?" and Display M≥nu C

41 - Upper Extremity Ask "Body Side (R or L)?" and Display Menu D 5 - lower Extremity Ask "Body Side (R or L)?" and Display Menu E

Menu B

Cervical or Lumbar Spine Options

0 - All Automatically cycles through options 1-4 -1 - Flexion

2 - Extension Prompts technician through sequence of

3 - Lat. Flexion coordinate measurements used to compute

4 - Rotation appropriate cervical or lumbar ROM angle

Msnu C Scapula Options

CP -All Automatically cycles through options 1-4

1 - Upward Rotation

2 - Downward Rotation Prompts technician through sequence of

3 - Adduction coordinate measurements used to compute

4 - Abduction appropriate scapular ROM angle

Msnu D Upper Extremity Options (See following pages) TABLE 12 Cont.

Msnu E

Lower Extremity Options (See following pages)

Menu D Upper Extremity Options

0 - All Automatically cycles through(Options 1-4

1 - Shoulder Displays Menu F

2 - Elbow Displays Menu G

3 - Wrist Displays Msnu H

4 - Hand Displays Menu I

Menu F Shoulder Options

0 - All Automatically cycles through options 1-5

1 - Flexion

2 - Exterision . Prompts technician through sequences of

3 - Abduction coordinates measurements used to ccπpute,

4 - Internal appropriate shoulder ROM angles

Rotation

5 - External Rotation

Msnu G Elbow Options 1 - Ext/Flex Prompts technician through sequences of coordinate measurements used to compute appropriate elbow ROM angles

Msnu H Wrist Options

0 - All Automatically cycles through options 1-4

1 - Flexion

2 - Extension Prompts technician through sequences of

3 - Ulnar Deviation coordinate measurements used to ccπpute

4 - Radial Deviation appropriate wrist ROM angels TABLE 12 Cent.

Menu I

Finger Options

0 - All Automatically cycles through options 1-10

1 - MCP Flex Thumb

2 - MCP Flex Dig 2

3 - MCP Flex Dig 3

4 - M:P Flex Dig 4 Prompts technician through sequences of

5 - MCP Flex Dig 5 coordinate measurements used to compute

6 - PIP Flex Thumb appropriate finger ROM angles

7 - PIP Flex Dig 2

8 - PIP Flex Dig 3

9 - PIP Flex Dig 4

10 - PIP Flex Dig 5

Menu E

Lower ^• Extremity Options

0 - All Automatically cycles through options 1-4

1 - Hip Displays Msnu J

2 -•Knee. Displays Menu K

3 - Ankle Displays Menu L

4 - Foot Displays Menu M

Msnu J Hip Options

0 - All Automatically cycles through options 1-7

1 - Flexion

2 - Leg Raise

3 - Extension Prompts technician through sequences of

4 - Abduction coordinate measurements used to ccπpute

5 - Adduction appropriate hip ROM angles

6 - Medical Rot.

7 - Lateral Rot.

Menu K Knee Options

1 - Extension/Flexion (No choices, test executes) TABLE 12 Cent.

Menu L - Ankle Options

0 - All Automatically cycles through options 1-4

1 - Dorsiflexion

2 - Plantarflexion Prompts technician through sequences of

3 - Inversion coordinate measurements used to cαrpute

4 - Eversion appropriate ankle ROM angles

Menu M

Toe Options

0 - All Automatically cycles through options 1-10

1 - MTP Flex G. Toe

2 - MTP Flex Dig 2

3 - MTP Flex Dig 3

4 - MTP Flex Dig 4 Prompts technician through sequences of

5 - MTP Flex Dig 5 coordinate measurements used to compute

6 - MTP Ext G. Toe appropriate toe ROM angles

7 - MTP Ext Dig 2 - .8 - MTP Ext Dig 3

9 - MTP Ext Dig 4 10 - MTP Ext Dig 5

TABLE 13

SUMMARY OF RANGE OF MOTION TEST SITES,

ACTIONS, BODY LANDMARKS, LANDMARKS MEASURED,

AND REFERENCE BODY POSITION

I.D. Site Action Landmark A Landmark B Re

1 Cervical Flexion Mandibl : pes Frontal Suture 3

2 Spine Extension II :Center 3

3 Lat. Flexion Left II It 3

4 Lat. Flexion Right II II 3

5 Rotation Left Left Zygomatic Right Zygomatic 2

6 Rotation Right It II 2

7 Lumbar Flexion SI and L5 LI and T12 3

8 Spine Extension II II 3

9 Lat. Flexion Left II II 3

10 Lat Flexion Right II II 3

11 Rotation Left L & R L & R 2

12 Rotation Right Iliac Crest Acromion Process 2

13 Scapula Up Rotation * *

14 Down Rotation

15 Abduction \

16 _* Adduction *

17 Shoulder Flexion Acromion Process Humerus Lat. τ

18 Extension II Condyle 2

19 Abduction II II 3

20 Adduction II II 3

21 Msd. Rotation Olecranon Process Styloid Process 3

22 Lat. Rotation It II 3

23 Elbow Ext/Flex II II 2

24 Wrist Flexion 3rd Metacarpal: 3rd Metacarpal: 1

25 Extension Carpus Phalanx 1

26 Abduction It It 1

27 Adduction ■t II 1

28 Hand MCP Flex Thumb * *

29 MCP Flex Digit 2

30 MCP Flex Digit 3

31 MCP Flex Digit 4 •

32 MCP Flex Digit 5

33 PIP Flex Thumb

34 PIP Flex Digit 2

35 PIP Flex Digit 3

36 PIP Flex Digit 4

37 PIP Flex Digit 5 TABLE 13 Cent.

38 HIP Flexion Greater Trcchanter Femur: Lat 2

39 Leg Raise II Candyle 2

40 Extension II II 2

41 Abduction II II 2

42 Adduction II It 2

43 Med. Rotation Tibial Tuberosity Medical Malleolus 2

44 Lat. Rotation II It 3

45 Knee Ext/Flex Hands of Fibula Lat. Malleolus 2

46 Ankle Flexion 3rd Mstatarsal: 3rd Metatarsal 1

47 Extension Tarsus Digits 1

48 Inversion It II 1

49 Eversion It II 1

50 Foot MTP Flex Toe * *

51 MTP Flex Digit 2

52 MTP Flex Digit 3

53 MTP Flex Digit 4

54 MTP Flex Digit 5

55 MTP Ext. Toe

56 MTP Ext. Digit 2

57 MTP Ext. Digit 3

58 MTP Ext. Digit 4 _*•

59 MTP Ext. Digit 5

Note: Lumbar spine has 4 landmarks, e.g. landmark A = SI, B + L5, C = LI, and D = T12

These sites are not yet available for measurement

IV. Software

Software was designed so that the DEC RT-11 operating system is transparent to the technician. Emphasis was placed on ease of use and minimization of human error. Many repeatable and predictable functions (file naming, averaging of trails, printing formats, etc) are automated to increase testing and data handling speed while limiting the required instruction set to basic commands. Thus, experience with software is not required to gain expertise in test administration. These goals are achieved with a specially designed monitor system for test administration and a data management system for result printing and statistical analysis.

A. Monitor system

A separate floppy disk for each patient is inserted into the reserve rive during testing. All neurologic function "run" files reside on a floppy disk in the system drive. Upon running the monitor system program, the technician is prompted for the date and time. The patient's identification number is then requested (usually, the Social Security number). If this is the patient's first examination session, a patient data file (PATDAT.000) and a test result directory file (FILDIR.DAT) are automatically created. The technician is prompted for the patient name which is included in PATDAT.000 along with the identification number. Should the file already exist, the name prompt is skipped. The typed identifica¬ tion number is compared with the stored number and if different, the technician is prompted with "Was correct ID typed (Y or N)?". An "N" response causes a "WRONG DISK?" message to be printed and the identification prompt to be reissued, while a "Y" response allows the user to re-enter the ID number. Following successful execution of these tasks, the technician is allowed to enter up to 100 lines of narrative text. Narratives and corresponding dates entered during successive sessions are stored in sequentially named formatted files (PATDAT.001,

PATDAT.002, etc.). The file index (suffix) for the next narrative file is contained in PATDAT.000 and is updated each time a new narrative file is created.

Next, an exclamation point prompt is issued indicating the program is ready to receive 1 of 19 commands (17 test names, time request, and test name menu request - each 6 characters maximum) . An expandable look-up table is used to reject invalid commands and set bits in a switch word that corresponds to test parameter questions (mode, body side, extremity, duration, etc.) that must be asked^*for the selected test. Upon receipt of a valid tes^'t name and prompting/entering test parameters, the proper test administration subroutine is executed. Following test completion, a "SAVE DATE" (Y or N)?" question allows the technician to reject data obtained from practice or invalid trials. A "Y" response causes present test parameters, time of test completion, and results to be saved in a master result buffer. Completing this function or an "N" response initiates printing of a "RETEST (Y or N)?" question. If an "N" response is entered, the master result buffer is written to disk in the form of an automatically named file, i.e. TREMOR.000. The exclamation point prompt is again printed and the monitor waits for a new command. In this case, the file name is generated from the name used to select the test and the appropriate index as obtained from a constantly updated look-up table stored in FILDIR.DAT. If the response to the "RETEST?" question is "Y", the technician is asked "NEW PARAMETERS DESIRED (Y or N)?". If so, the technician is prompted to enter them. Otherwise, the test executes with the previously entered parameters. The contents of an iteration counter, reflecting the number of times a test was executed with the same parameters, are printed during execution. Note that a data file is not written until a negative response to the "RETEST?" question occurs. Intermediate test results are temporarily saved in the master result buffer sequentially until that time. This, buffer also contains reserved space for the date and number of trials saved. A monitor of this design allows the technician to create versatile examination protocols around time-saving, self-structured, automated subunits. Prompts with choices and the request- able menu minimize responsibilities, allowing the technician to monitor the patient. Consistent use of look-up tables facilitates expansion should new tests be required. „

B. Data Management

Data management in large-scale battery testing has traditionally presented significant problems. Previously, data had to be hand recorded and keypunched in various formats. Cards had to be sorted and hand labeled with subject information, date, etc. for future use. Unlike most biomedical research where there are many data points of similar type (i.e. pressure vs. time), in this case there are single number results of many different data types which must be kept separate.

The design of the monitor system with individual patient disks, systematic generation of file names, and automatic inclusion of dates, parameters, and times as part of the stored "results" greatly facilitates automated data management. Because- of this structure, routines were easily written for printing individual results according -73-

to several desirable formats by answering three questions: (1) "SPECIFIC FILE NAME? (DEFAULT-NO)"; (2) "TEST NAME? (DEFAULT-ALL)", and (3) "DATE? (DEFAULT-ALL)". Thus, printing may be requested for results in: (1) a given 5 file; (2) all files of a given test on a given date; (3) all files of a given test on all dates; (4) all files of all tests on a given date; and (5) all files on all dates.

Proper formatting of data for group statistical 10 analysis is equally automated and simplified. While running a formatting routine, patient disks are inserted one at a time. File names are generated and files are read while stored parameter date and data information are used to extract and place data into separate matrices of 15 common format for each date. Each matrix row corresponds to a different subject_, while each column represents different measures (dominant side simple reaction time, . etc.). ^"Undefined columns are left 'for new measures. • These matrices are subsequently stored in automatically 20 named files (DATA:000, DATA:001, etc.) on the system disk, where they can be expanded row-wise as needed.

c System Organization

25

Figures 7a-7d illustrate flowcharts for four different embodiments, detailing system functions and relationships between major components for each. Test sites are equipped with application independent test

30 batteries or measurement systems. Clients 5 are referred to test sites for measurements and analyses by service providers 4. A series of human performance tests are administered and results are entered into a central mainframe computer where data base and processing

35 algorithms reside. Service providers utilize either computer terminals, or personal computers with application dependent intelligent software to obtain quantitative measurement results or automated analyses of human perfor¬ mance measurements.

The client 5, depending on the application (reason for being evaluated), could be (a) a "normal subject", requiring a periodic checkup for general functional fitness screening or early problem detection; (b) an undiagnosed patient, requiring diagnosis and documentation of relevant functional status; (c) a diagnosed patient undergoing treatment/rehabilitation, requiring followup documentation of functional status to be used by clinician/service provider 4 to fine tune or determine effectiveness of treatment/therapy; (d) a rehabilitated patient, stable but with less than normal function, requiring documentation of functional status to be used to asse^'ss abilities in other areas such as activities of • daily living, vocations, etc., or (e) an aspiring athlete or pre-professional student in a discipline requiring special, high level human performance abilities (e.g. dance) desiring to document present performance and predict potential for success in a chosen field. In medical applications, service provider could be physical therapists, occupational therapists, neurologists, ortho- pedic surgeons, physiatrists, vocational counselors, internists. Yet in other applications, they could be an athletic coach or trainer, a teacher, the client him or herself, or a new (yet to be defined) professional with expertise in human performance assessment (made possible by availability of proposed technology).

1. Data Acquisition Embodiment Differences

In the Embodiment I version (Figure 7a), a subjective impression (Preliminary Diagnosis) and specification of desired quantitative measurements 6 would be provided by the service provider after an initial subjective observa¬ tion screening interview. This information includes diagnostic category (normal, Parkinson disease, etc.) as well as a general checklist of type of measurement profile required (complete workup, body site workup, function workup, individualized workup) .

In Embodiment II (Figure 7b), an automatically generated specification of tests to be administered 23 replaces the subjectively-derived test specification 6 provided by the clinicial service provider 4. Interactive software 21 is used to obtain information directly from the client. A menu oriented query/response format is used to determine (a) the client's primary category (athlete, patient, etc.), (b) symptoms, complaints (for patients) er further categorization and desired purpose of evaluation ^■(for others). Depending on client menu selections during interaction with interactive software 21, intelligent processing software and knowledge base I 22 are used to generate a complete list of tests (in table form) to be administered. Test administration thus proceeds in a table driven mode, prompting the technician through the series of tests.

In Embodiments III (Figure 7c) and IV (Figure 7d) , intelligent processing software and knowledge base I 21 are used to generate specification of initial tests to be administered 24, which is subsequently used in a test sequencing scheme based on a hierarchical view of human functions. In this scheme, client responses to inter¬ active questioning and the raw test results from the initial test (or first several tests) 25 are used by intelligent processing software with reference to know- ledge bases I 22 and II 26 to generate specification of the next test (test J+l) 27. This method assumes that certain functions must be present at or above a specified level in order for it to be meaningful to measure functions higher in the hierarchy. Thus, testing proceeds through the hierarchy to a given site while results are monitored. Intelligent software makes decisions to proceed to higher levels or to stop. Several hierarchical structures, with subtle differences from each other are required for different client categorizations.

2. Test Battery Description

By whatever means test protocols and sequencing are selected, tests are administered to the client with use of the unique computerized, instrumented test battery 1.

This is a measurement laboratory with the means to acquire quantitative information on a broad range of .human perfor¬ mance characteristics, such as -basic sensory and motor, cognitive, and physiologic functions (described in detail in proceeding sections). The test battery is designed to obtain basic measures of function with a choice of measures and methods of measurement designed so that the battery can be considered to be application independent. Figure 8 summarizes functions and body sites included in the battery. For a single patient, at least one dot in this matrix is replaced with at least one quantitative or test battery measurement. The test battery subsystem is modular and can be configured as a whole for some applications, or as smaller systems for others.

Figure 9 is a more detailed breakdown of interface/support hardware modules and associated peripheral stimulators and transducers shown in Figure 1. Modules 38 serve to interface either transducers, stimuli generators, or a combination of both. Each peripheral device, 39 through 60 as described in preceding sections. has been uniquely designed, to allow measurement of one or more functions quickly and accurately during short duration (most 5-30 sec, some 2 minutes) test trails which require the client to carry out a well defined task. More than 500 measures can be collected, the number and selection depending on the application.

3. Processing

Referring again to Figures 7a-7d, , the most basic form of output from the test battery is raw test results 7. Raw results have units of basic physical quantities (msec, kg, degrees, etc.) related to the manner in which a particular function is characterized. Raw test results contains result for each trial of an administered test, although several trials of some tests are administered intentionally for use in generating a final, reliable "score". The scheme used depends on the given test. A typical session can consist of 10 to several hundred short duration trials. Raw result files are generate for each type of test. Refer to Figure 10 for a summary of raw result file formats.

A formatted, printed version of raw test results 8 is generated upon completion of the test administration. Some service providers (primarily researchers) will find this level of information to be useful. It does document level of function, but is difficult to interpret (in terms of "good" or "poor") unless considerable experience is gained with raw results across wide populations.

For use in other aspects, raw test results are presented to a "DECIPHER" program 9. This software executes a complex process whereby all raw test result files 7 on a subject's floppy disk are scanned and processed (for example: all results of some type of trial from given test session averaged, or best 2 of 3 averaged, or best of 3 selected) to generate a Function Profile Data Record 10. Alternatively, raw test results may be printed directly in the form of a raw result printout 8 if

"deciphering" is not required. (Refer to Figure 10 for more detailed visualization of DECIPHER and interface to raw test result files).

The Function Profile Data Record 10 consists of a formatted, reduced version of raw test results with one measure or set of measures describing each function. Viewed in the format of Figure 8, this set of measures forms a raw data profile matrix. The data record also contains basic information regarding client demographics and categorization.

In one aspect, a function profile printout 11 is generated. This consists of a formatted printed version of the complete data record which is still difficult to interpret and simply represent a reduced or compressed form of raw results 7.

In another aspect, the local "COMPARE" program 13 is used to generate a normal population comparison printout 13. Using a "characteristic snapshot" of the established central sensory and motor function data base 2, this software facilitates transformation of a given data record from raw results units to units of standard deviation from user selected subset of a normal comparison population. For many medical applications, such a following progress during therapy, a client is compared to norms selected by age decade and gender. Note that this capability resides on the local computer used for test administration and that printouts can be obtained immediately after a test session in the laboratory for transmittal to the referring service provider.

In other aspects, program "DBTRANS" 14 is used to enter the function profile data record into the central data base 2. This program is a nonunique software package, running on the local test battery computer 29.

Within the central sensory and motor function data base 2, there are actually many separate RECORD DATA

BASES, one for each remote test site, which with the use of program MFRMAT 15 can be viewed in a virtual sense as a single sensory and motor function data base. Population characteristic files are kept updated each time a new record is entered, so that mean and standard deviations for each client category, for each system measure, are. updated. As previously noted, data is entered and indexed in the central data base with reference to both^' subjective and objective diagnostic evaluation of the patient from whom the data was derived. As the central data base is enlarged, the precision of the diagnostic information obtained for any given patient or client is accordingly increased. In one sense, the indexed diagnostic infor¬ mation residing in the central data base can be viewed as a form of application dependent knowledge 16.

In some aspects, the data base, or collection of population characteristic files, is drawn upon by APPLICATION DEPENDENT FORMATTING AND/OR PROFILE ANALYSIS SOFTWARE 17 which resides either at the service provider location on personal computers 3 or, for more general use formats and analyses, resides on the mainframe computer.

Lookup table oriented routines are used to generate useful Result Formats 18. A separate lookup table (using measure reference numbers) is used to identify basic measures with application oriented labels for major functional categories and measure names. Thus, different function category and measure names can be applied to the same source measure to generate suitable report forms for each application discipline.

Report formats can be either numerical or graphical. Examples in numerical reports are presented in Figures 4, 5, 11-12. Figure 14 illustrates what is termed a "standard report" because of its popularity. This- report contains measurement results after comparison of raw results to characteristics of a selected population. The report consists of a header 109, major function category labels 110 and measurement labels 111, and measurement scales (left body side 112, right body side 113, and side independent 114) in standard deviation units (from selected comparison population).'

Figure 5 illustrates a COMPOSITE STANDARD REPORT, similar to Figure 4, but with a single result for each major function category. The basic components of a composite are a header 109, major function category labels 110, measurement scales 112, 113, 114, a numeric variable 116 for each category, a numeric variable 117 showing the number of measures for which data was acquired, a "lowest function" measurement marker 118, a "highest function" measurement marker 119, and a "weighted" average measure¬ ment marker 120.

Figure 11 illustrates a sample TREND REPORT. This report is used to observe and document changes in function over time. It consists of a report header 109, a result identifier field 121, category or measurement labels 122, category/measurement symbolic identifiers 123, date of test session labels, a measurement scale 125, and measure¬ ment result bars. In the result identifier field 121, categories or measurement labels are assigned to symbolic identifiers 123 which are used to generate bars 126 in the graphical portion of the report. In this way, a user can select multiple items to be included in the report, each of which would appear on the chart represented by a measurement bar composed of a different symbolic identifier.

Printed tabular reports have certain limitations in that all information must be conveyed in words and numbers, whereas some details (such as the body site associated with a particular measure) could be conveyed graphically. In another aspect. Functional Profile Visualizations are utilized to present clear and concise visualizations of a patient's performance, based on quantitative measurements and normative components of the central data base 2. This approach is motivated by the desire for generalized screening procedures^' and to obtain a format by which the many measurements can be quickly interpreted. The approach is designed to limit the amount of user-related operations to the minimum required for data screening. Graphics are designed to translate a function profile data record 10 into a body site oriented visual presentation. The basic components of the Function Profile Visualization aspect are shown in Figure 12. The user's responsibility is limited to entering of the patient's identification and selection of the population to which he/she should be compared by responding to specification prompts 127.

A category menu 128 is provided to allow the user to restrict display content to only major functions of interest. Any combination of listed categories can be selected. The program suppresses the display of measures which were not collected during a given test session. A function profile data record 10, transformed to the form of standard deviation units, is converted into a series of colored spots 129 on a video screen (or shaded spots on a printed page) 131. Each spot uniquely refers to 27 different body sites on a displayed outline of a human figure 130. Color selection (or print shading) is mapped to individual test results (example: red (light shading) = 3 S.D. units below comparison mean; green (medium shading) = 0 S.D. units; blue (dark shading) = 3 S.D. units above comparison mean), according to a displayed scale legend 132. The overall display is actually a composite in that the numerical value used as the basis of spot color for each body site us the average of all tests (across functions such as strength, range of motion, etc.) selected from the category menu 128.

.More detailed information can be requested by positioning a keyboard-controlled cursor 133 (shown as a smaller white spot inside the lowest right hand spot in 131) over a desired body site spot 129. A breakdown table 134 is then displayed containing names of all measures used to form the composite color at the selected body site, along with color-coded representation of measured function level.

In more sophisticated aspects (refer to Figures 7a- 7d), application dependent profile analysis programs 19 are used to generate results (e.g.-"diagnoses") which are simpler in format or content, but more powerful. Examples of such results are: (a) probability for success in specified vocations (for a rehabilitated and stable, but handicapped, individual) or (b) probability for success in a profession requiring highly developed sensorimotor skills (dancer, musician, surgeon), (c) "percent disability" in insurance industry terms, (d) anatomic lesion sites (for example "upper motor neuron" lesion or "cerebellar" lesion) in the nervous system, (e) predictions of probable diagnoses such as Parkinson disease or multiple sclerosis. In these aspects, profile analysis programs 19 draw upon the CENTRAL HUMAN FUNCTION/PERFORMANCE DATA BASE 2 and APPLICATION DEPENDENT KNOWLEDGE AN/OR DATA BASES 16. The result of such analyses can be considered to be an assessment of the results. In aspects representing a next level of sophistication (Embodiment IV, Figure 7d) , treatment plan suggestions or other application dependent actions plans 28 are generated. These are obtained by a combination of lookup tables (assessment B leads to plan B) and plan generation rules, determined by experts representing a particular service provider discipline, and based on profile analyses 19.

Figure 13 represents a summary descriptive diagram for test administration software. Program INITIALIZE 61 establishes a client information file 63 (name, gender, date of birth, preferred handedness, etc.) from test administration technician keyboard entries 62. Control is passed to program CMNDGET 64 which draws upon command identification rules 65 to process test administration and is used to select major test categories (speed, coordination, strength, range of motion, tremor, etc.) or supervisory function (health, time of day, etc.), entered by way of the keyboard. Any command entered is processed to determine a representative valid supervisory function 66 or valid test identification 70.

Valid supervisory functions are processed by program FNSORT 67 which draws upon an expandable set of function execution program files 68 to enable execution of the supervisory function selected 69. A valid test command identification 70 is processed by program CMNDPROC 71 which draws upon a test mode/site prompt table 72 to prompt the technician for further specifications of the test desired (e.g., if coordination test is selected now a modality, "slow or fast coordination", and body site, "trunk", can be specified).

Complete specification information is passed along with control to program TEXEC 73. TEXEC 73 utilizes these specifications to select specific execution software from test execution program files 74. TEXEC 73 thus performs the selection and supervises actual execution. Data acquisition appropriate to the test selected is controlled by the specific test execution program selected.

Upon completion of the test, usually 5 to 60 seconds later, control is passed to program RESPROC1 75. This program generates the trial result 77 in core memory and utilizes test specification information. The results file directory file 80, which contains a directory of previous test results, and result file naming rules 81 are used to generate a named raw result file 82.on disk magnetic storage media. A TESTMAP file 79 is also generated which represents a vector with one data entry per measurement in the system. Three entry choices are available ("0"-test not done,"l"-test measure obtained, and "-l"-client is unable to execute test).

All communications with disk media are accomplished by way of the disk I/O buffer 78, a set aside portion of core memory. Decisions concerning when a raw result file 82 is to be saved are handled by way of administration flow control prompts 76. These permit the technician to repeat a test trial of the same type already specified (control passed to program TEXEC 73) or select measurement of an entirely new function (control passed to program CMNDGET 64) . The following example demonstrates the usefulness and applicability of the present system in the quantitative" functional assessment and characterization of head injured patients.

EXAMPLE I. HEAD-INJURED PATIENTS

^• Head injury often leads to functional problems in cognitive, psychologic (emotional), and physical (sensory and motor) areas. Evaluation of the latter has previously been in terms of general or gross categories such as mobility, and often only end treatment function has been reported. Aside from dexterity assessment with the Purdue pegboard, detailed physical function evaluations from date of stabilization after injury*through the end. of rehabilitation has not been commonplace. Most of the previous studies rely on coded rating scales, which have sensitivity and reliability limitations! Standardized rating scales have yet to become accepted, perhaps because of these limitation.

In the present study, fifteen head injury patients, 12 males and 3 females, were tested on a selected subset of tests in the computer-automated system. Age ranged from 17-39 years with a mean age of 26.67 years. Time from injury onset to test date ranged from 3-27 months with a mean of 10.07 months. With the exception of one subject, all tests were completed in one session per subject. The same examiner, a trained occupational therapist, administered all tests. The 62 measures of function obtained are listed in Table 14 by descriptive name and are grouped by functional category (dominant and nondominant side are considered separate measures). Each test listed lasted approximately 5 to 20 seconds. As with all subjects evaluated, demographic information was obtained at the start of the session and was recorded with test results on each subject's floppy disk.

TABLE 14

Measures of sensory and motor function obtained from 15 head injured patients

VISION UPPER EXTREMITY SPEED Central visual efficiency, R and L eye Index finger tapping, D and ND Hand-arm tapping, D and ND

MEMORY Lateral alternating reaching , D and Short-term 2 choice rnovement, D an ND 8 choice movement, D and ND

ACTIVITIES OF DAILY LIVING Arm sweep, D and ND Putting on a shirt Zipping a zipper UPPER EXTREMITY COORDINATION Tying- a bow Lateral reaching and tapping - D and N Buttoning large button Hand-eye random target tracking - Buttoning small button D and ND (measures each) Manipulating safety pins Threading a needle LOWER EXTREMITY STRENGTH Foot dorsiflexion - D and ND

MANUAL DEXTERITY Extended leg flexion - D and ND Large peg manipulation, D and ND Purdue pegboard, D and ND LOWER EXTREMITY REACTIONS Simple visual reaction time,

UPPER EXTREMITY STRENGTH D and ND^'foot Grip, D and ND Wrist dorsiflexion, D and ND LOWER EXTREMITY SPEED Extended arm abduction, D and ND Foot tapping, D and ND Lateral reaching leg swing,

UPPER EXTREMITY REACTIONS D and ND Simple visual reaction time, D and ND hand LOWER EXTREMITY COORDINATION

2 choice reaction time, D and ND hand Lateral reaching and tapping - 8 choice reaction time, D and ND hand D and ND Arm sweep reaction time, D and ND hand

Note: D - dαninant side.

ND - nondominant side.

Test results were first processed to form a data record, a procedure that involves processes such as averaging the best 2 of 3 trials of a particular test. Each data record was then entered into the sensory and motor function data base management system. With special features in the data base management system, each patient's data record was compared to a normal population of the same gender and age decade to produce results for each test in terms of the number of standard deviation units from the normal population mean. For most tests, 'our normal data base in this age range is fairly robust, with more than 50 observations for each measure. To facilitate presentation of results in the limited space available, the simple average (no weighting factors) of all measures within a function category was computed to form a category composite result.

Results are presented_, as function profiles as. shown in Figures 14a, b and c Figure 14a represents the average and range for the 15 patient population in each of twelve major function categories. The least disability is indicated for vision, memory and upper and lower extremity strength and speed. Figure 14b shows a similar plot for a patient 3 months post injury, showing functional below that of the group in most categories, while Figure 14c illustrates the functional profile for a patient 27 months post injury.

Results are not presented to make a major statement about function in head injury patients, but rather to demonstrate the possibilities for undertaking studies that may do so. It is concluded that tests in the computer- automated battery can be administered to the head injured population and that functional profiles of the type presented can be useful to track patient progress and document rehabilitation trends. Figure 14a demonstrates that physical function is extremely variable in this population, as expected. While individual results are presented for two patients, one recently injured and the other injuired more than two years prior to the test date, no attempt was made to normalize results based on severity of the initial injury. Unfortunately, data for the second patient at 3 months post injury was unavailable for comparison. Therefore, while the plots demonstrate the expected trend (the patient further from injury date has better function), there were exceptions to this trend in the data set. Such excepitons were found to be strongly correlated with the nature and severity of the initial injury, as evidenced by other medical information available.

It should be noted that most tests were administered to right and left body, sides. In the above results, right and left side results were averaged, but could easily be displayed as separate profile points.

With a variety of head injury recovery trends possible, as well as a choice of rehabilitation methods, the availability of a broad scope quantitative test battery to evaluate these trends and treatment modalities effecitvely is presented. Questions such as, "When should therapy (or a portion of a therapy program) be discontinued?" could be answered based on hard data. The system also provides the capability of objectively documenting changes in functioning for rehabilitation reimbursement purposes, important for treatment of other populations in addition to the head injured. The foregoing description has been directed to particular embodiments of the invention in accordance with the requirements of the Patent Statutes for the purposes of illustraiton and explanation. It will be apparent, however, to those skilled in this art that many modifi¬ cations and changes in the apparatus and procedure set forth will be possible without departing from the scope and spirit of the invention. It is intended that the following claims be interpreted to embrace all such modifications and changes of the use of other features, all as would be apparent to one skilled in the art after having the benefit of this description of the invention.

Claims

CLAIMS :

1. Apparatus for determining the motorsensory functional status of a patient comprising:

(a) at least one human motorsensory function trans¬ ducer for generating electronically encoded impulses in response to a selected patient motorsensory performance test;

(b) processing means, connected to be responsive to the transducer generated impulses, for pro¬ cessing the impulses to produce a raw patient function data matrix;

(c) comparing means, connected to be responsive to the processing means, for comparing the -raw patient function data matrix to raw function data matrices from a selected population subset to generate a population comparison profile data matrix; and

(d) display means, connected to be responsive to the comparing means, for displaying the profile matrix in units of deviation from the selected population raw function data matrices.

2. The apparatus of claim 1 further comprising display means, connected to^' be responsive to the processing means, for displaying the raw patient function data matrix.

3. The apparatus of claim 1 further comprising stimulus means positioned for eliciting a motorsensory response from the patient.

4. The apparatus of claim 1 or 3, further comprising:

(a) at least one central human function and performance data matrix having stored raw function data from human populations, the data being indexed in the central matrix in terms of selected population characteristics; and

(b) characterizing means, connected to be responsive to the raw patient function data matrix and the central performance data matrix, for charac¬ terizing the motorsensory functional status of the patient in terms of human populations characterized by corresponding raw function data matrices.

5. Apparatus for determi-ning the motorsensory functional status of a patient comprising:

(a) at least one human motorsensory function trans¬ ducer for generating electronically encoded impulses in response to a selected patient motorsensory performance test;

(b) processing means, connected to be responsive to the transducer generated impulses, for pro¬ cessing the impulses to produce a raw patient function data matrix;

(c) a population profile data matrix having stored raw function data from a human population, the population data being indexed in terms of selected motorsensory function tests; (d) comparing means, connected to be responsive to the processing means and the population profile matrix, for comparing the raw patient function data matrix to raw function data matrices from a selected population subset to generate a population comparison profile data matrix; and

(e) display means, connected to be responsive to the comparing means, for displaying the profile matrix in units of deviation from the selected population raw function data matrices.

6. Apparatus for determining the motorsensory functional status of a patient comprising:

(a) at least^" one human motorsensory function trans¬ ducer, for generating electronically encoded impulses in response to a selected patient motorsensory performance test;

(b) processing means, connected to be responsive to the transducer generated impulses, for pro¬ cessing the impulses to produce a raw patient function data matrix;

(c) at least one central human function and performance data matrix having stored raw function data from human populations, the data being indexed in the central matrix in terms of selected population characteristics; and

(d) characterizing means, connected to be responsive to the raw patient function data matrix and the central performance data matrix, for charac¬ terizing the motorsensory functional status of the patient in terms of populations characteri¬ zed by similar raw function data matrices.

7. The apparatus of claim 6 further comprising stimulus means positioned for eliciting a motorsensory response from the patient.

8. The apparatus of claim 6 or 7 further comprising display means, connected to be responsive to the charac¬ terizing means, for displaying the patient's characterized motorsensory functional status.

9. A method for determining the motorsensory functional status of a patient comprising:

(a) subjecting the patient to at least one motor- sensory performance test monitored by a selected motorsensory function transducer which generates electronically encoded impulses in response to the test;

(b) processing the transducer generated impulses to produce a raw patient function data matrix;

(c) comparing the raw patient function data matrix to raw function data matrices from a selected subset to generate a population comparison profile data matrix; and

(d) displaying the profile matrix in units of deviation from the selected population raw function data matrices.

10. The method of claim 9 of further comprising displaying the raw patient function data matrix.

11. The method of claim 9 wherein subjecting the patient to at least one motorsensory function test further com¬ prises stimulating the patient to elicit a selected motorsensory response and orienting the motorsensory transducer to generate electronically encoded impulses which correspond to the patient's motorsensory response.

12. The method of claim 9 or 11 further comprising:

(a) storing raw motorsensory function data from human populations in a central human function and performance data matrix;

(b) indexing the stored function data in terms of selected population characteristics; and

(c) determining the motorsensory functional status of the patient by characterizing the raw patient function data matrix in terms of human popula- tions characterized by corresponding raw function data matrices.

13. A method for determining the motorsensory functional status of a patient comprising:

(a) subjecting the patient to at least one motor¬ sensory performance test monitored by a selected motorsensory function transducer which generates electronically encoded impulses in response to the test; (b) processing the transducer generated impulses to produce a raw patient function data matrix;

(σ) storing raw motorsensory function data from human populations in a central human function and performance data matrix;

(d) indexing the stored function data in terms of selected population characteristics; and

(e) determining the motorsensory functional status of the patient by characterizing the raw patient function data matrix in terms of human popula¬ tions characterized by corresponding raw function data matrices.

14. The method of claim 11 wherein subjecting the patient to at least one motorsensory function test further com- prises stimulating the patient to elicit a selected motorsensory response and orienting the motorsensory transducer to generate electronically encoded impulses which correspond to the patient's motorsensory response.

15. The method of claim 11, 12 or 13 further comprising displaying the patient's characterized motorsensory functional status.