WO2002060311A2

WO2002060311A2 - Physiologically active bracing

Info

Publication number: WO2002060311A2
Application number: PCT/AU2002/000091
Authority: WO
Inventors: Jeffrey David Edwards; Robert Gilmour
Original assignee: Genesis Biomedical Limited
Priority date: 2001-01-30
Filing date: 2002-01-30
Publication date: 2002-08-08
Also published as: WO2002060311A3; AUPR277401A0

Abstract

A physiologically active brace (10) is disclosed which includes a mechanical support structure (12) adapted to be worn by a user in connection with a part (14) of the body, therapeutic means mounted on the support structure (12) for applying a prescribed therapy for a user to the body part (14), a therapy control unit (24) for automatically controlling operation of the therapeutic means, and a storage medium reading device (26) operatively connected to the therapy control unit (24). The therapy control unit (24) is responsive to predetermined control instructions derived from the prescribed therapy for the user. The reading device (26) is arranged to receive a removable non-volatile information storage medium on which is stored the predetermined control instructions, and to read the predetermined control instructions from the storage medium. In use, the therapy control unit receives the predetermined control instructions from the storage medium and the therapeutic means applies the prescribed therapy without the need for close human supervision. A corresponding method is also disclosed.

Description

PHYSIOLOGICALLY ACTIVE BRACING

The present invention relates to a physiologically active brace and method of bracing and relates particularly, though not necessarily exclusively, to such a brace which is capable of administering a prescribed therapy in a progressively varying manner.

Bracing of injured or weakened limbs and other parts of the body has traditionally involved total immobilisation of the body part using some form of brace or splint. However, as total immobilisation introduces tissue degeneration and greatly restricts the activities of the patient, alternative forms of bracing involving partial immobilisation have been developed. Braces designed to partially immobilise the affected body part prevent or secure those activities which need supporting but allow freedom of movement where this is safe. The market is currently dominated by this form of bracing.

More recently, a still further improvement in bracing methodology is sometimes referred to as active bracing. In active bracing a degree of therapy is provided by adding to a basic bracing platform various additional functions that can participate actively in the management of injury recovery. For example, a mechanically adjustable brace is known, in which spring loaded hinges allow incremental adjustments in resistance to be applied to the movement of the brace. This varies the degree to which the muscles in the affected body part have to work and can encourage tissue regrowth. However, this type of active brace is manually operated and periodical mechanical adjustments have to be made by the user or a therapist in order to vary the mechanical loading applied by the springs. Manually adjusted springs also provide no means of establishing, improving or refining a protocol or "prescription" against known outcomes.

The present invention was developed with a view to providing a physiologically active brace that overcomes at least some of the above-noted disadvantages of the prior art.

Throughout this specification the term "comprising" is used inclusively, in the sense that there may be other features and/or steps included in the invention not expressly defined or comprehended in the features or steps subsequently defined or described. The identity of such other features and/or steps will be apparent from the specification read as a whole.

According to one aspect of the present invention there is provided a physiologically active brace, the brace comprising: a physiologically active brace comprising: a mechanical support structure adapted to be worn by a user in connection with a part of the body; therapeutic means mounted on said support structure for applying a prescribed therapy for a user to said body part; a therapy control unit for automatically controlling operation of the therapeutic means, the therapy control unit being responsive to predetermined control instructions derived from the prescribed therapy for the user; and a storage medium reading device operatively connected to said therapy control unit, said reading device being arranged to receive a removable non-volatile information storage medium on which is stored said predetermined control instructions, and to read said predetermined control instructions from said storage medium; wherein, in use, the therapeutic control unit receives said predetermined control instructions from said storage medium and said therapeutic means applies the prescribed therapy without the need for close human supervision.

In one embodiment, the therapeutic means includes an electrotherapy device arranged to generate electrical and/or electromagnetic signals under control of the therapy control unit to stimulate the human body's healing processes to thereby produce a therapeutic effect.

Preferably, said electrotherapy device includes a therapy applicator for applying said electrical and/or electromagnetic signals through the skin of the user to a predetermined part of the user's body.

Preferably, the electrotherapy device is a transcutaneous electro-nerve stimulation (TENS) device, a micro-current electrotherapy (MET) device, a neuro-muscular stimulation (NMS) device, or a pulsed electromagnetic field (PEMF) device. Alternatively or additionally, the therapeutic means incorporates an adjustable movement restrictor for automatically applying variable amounts of restriction of movement to said body part under control of the therapy control unit to thereby produce a therapeutic effect. Typically, said movement restrictor is in the form of a tensioner for varying the tension applied to a hinge of the brace, and said prescribed therapy includes the sequential addition of small amounts of additional tension to the hinge in a predetermined manner to stimulate tissue regrowth.

In one embodiment, the adjustable movement restrictor includes a hinge, said movement restrictor is a tensioner arranged to variably apply tension to the hinge, and said prescribed therapy includes predetermined sequential addition of tension to the hinge to thereby stimulate tissue growth.

In an alternative embodiment, the adjustable movement restrictor includes a plurality of compression rollers, a peristaltic tube passing between the compression rollers and an actuator for adjusting flow of fluid to and from the peristaltic tube.

In a further alternative embodiment, the adjustable movement restrictor includes a boss provided on a first hinge element, a void defined by a second hinge element and arranged to receive the boss, and an actuator for increasing or reducing the diameter of the void so as to thereby increase or reduce friction between the first and second hinge elements.

Preferably, said therapeutic control unit is arranged to control said therapeutic means according to a prescribed sequence of therapy.

Preferably, said reading device is a memory card reader.

Preferably, the storage medium reading device is arranged to write information to said storage medium. Preferably, the mechanical support structure is adapted to be worn by a user in connection with a knee.

Advantageously, said predetermined control instructions include instructions for carrying out a series of sequential and/or timed events.

Preferably, the storage medium reading device is arranged to read a non-volatile information storage medium in the form of a portable memory card having a non-volatile programmable electronic memory device incorporated therein.

According to another aspect of the present invention there is provided a method of physiologically active bracing, said method comprising the steps of: providing a mechanical support structure adapted to be worn by a user in connection with a part of the body ; providing therapeutic means mounted on said support structure for applying a prescribed therapy for the user to said body part; providing a therapy control unit for automatically controlling operation of the therapeutic means, the therapy control unit being responsive to predetermined control instructions derived from the prescribed therapy for the user; programming a portable non-volatile information storage medium with the predetermined control instructions; and supplying the programmed information storage medium to a user for insertion in a storage medium reading device operatively connected to said therapeutic means; wherein, in use, the therapeutic control unit receives said predetermined control instructions from said storage medium and said therapeutic means applies said prescribed therapy without the need for close human supervision. In one embodiment, the therapeutic means includes an electrotherapy device arranged to generate electrical and/or electromagnetic signals under control of the therapy control unit to stimulate the human body's healing processes to thereby produce a therapeutic effect.

Alternatively or in addition, the therapeutic means includes an adjustable movement restrictor for applying variable amounts of restriction of movement to said body part under control of the therapy control unit to thereby produce a therapeutic effect.

Preferably, said predetermined control instructions include instructions indicative of therapy application rate, permitted frequency of therapy application and/or the timing of each application of the therapy.

Advantageously, the method further comprises the step of programming the information storage medium with identification information relating to a particular user, to the information storage medium and to a designated physiologically active brace, wherein only an identified user can use the information storage medium in the designated physiologically active brace. It is possible that said step of programming the information storage medium is carried out on-line by downloading said predetermined control instructions, preferably via the Internet.

Preferably, the method of physiologically active bracing further comprises the step of applying said prescribed therapy to the user in accordance with said predetermined control instructions. In one embodiment, said prescribed therapy is electrotherapy and said predetermined control instructions are designed to provide the correct therapeutic modality for each phase of treatment. In a further embodiment, said prescribed therapy involves applying progressively varying amounts of restriction of movement to said body part in accordance with said predetermined control instructions.

In order to facilitate a better understanding of the nature of the invention, preferred embodiments of the physiologically active brace and method of bracing in accordance with the invention will now be described in detail, by way of example, with reference to the accompanying drawings, in which: Figure 1 illustrates one embodiment of a physiologically active brace in accordance with the present invention;

Figure 2 illustrates schematically one embodiment of a method of programming a portable non- volatile information storage medium employed in the brace of Figure 1;

Figure 3 illustrates one possible arrangement of information stored on a non-volatile memory card similar to the arrangement illustrated in Figure 2;

Figure 4 illustrates one embodiment of a sequentially progressive hinge that can be employed in a physiologically active brace in accordance with the invention;

Figure 5 illustrates another embodiment of a sequentially progressive hinge that can be employed in a physiologically active brace in accordance with the invention; and,

Figure 6 illustrates a further embodiment of a sequentially progressive hinge that can be employed in a physiologically active brace in accordance with the invention.

A typical embodiment of a physiologically active brace in accordance with the invention is illustrated in Figure 1 in the form of a physiologically active knee brace 10. The knee brace 10 comprises a mechanical support structure 12, in this case adapted to be worn by a user on a leg in connection with the knee 14. The support structure 12 includes an upper support 16 which is strapped to the thigh of the user's leg, and a lower support 18 which is strapped to the user's leg below the knee. Both upper and lower supports 16, 18 may be made from semi-rigid, injection moulded, plastics material, and are pivotally connected by means of a pair of hinges 20 provided on respective sides of the knee 14. The brace 10 further comprises a therapeutic means provided in connection with the support structure 12 for generating and applying a prescribed therapy to the user's leg. In this case, the therapeutic means includes an electrotherapy device which generates electrical and/or electromagnetic signals to stimulate the body's natural healing processes to produce a therapeutic effect. The electrotherapy device includes a therapy applicator 22 for applying the electrical and/or electromagnetic signals through the skin of the wearer to a region of the leg just below the knee 14.

An electronic control means in the form of sequential therapy control unit 24 is mounted on the upper support 16 of the brace, and is designed to automatically control the operation of the electrotherapy device in accordance with predetermined control instructions adapted to provide the prescribed therapy for the user. In this embodiment, a read/write device in the form of a card receptor 26 is incorporated in the same casing as the therapy control unit 24 and is operatively connected thereto for reading or writing information from/to a removable non-volatile information storage medium. In this embodiment, the removable non-volatile information storage medium is in the form of a memory card, or so-called smart card (not illustrated in Figure 1), for storing information relating to the operation of the electrotherapy device, including the predetermined control instructions.

All required information relating to the operation of the therapeutic means provided in connection with the support structure 12 of the brace 10, including the predetermined control instructions, may be downloaded into the memory card using a memory card generation software package on a conventional desk-top PC 28 as illustrated in Figure 2. The memory card generation software package may be used to communicate with a commercially available or custom-designed memory card read/writer unit 30 which is adapted to removably receive a memory card 32 therein. Memory card 32 may be, for example, a free access EEPROM chip card with the capacity to store in non-volatile memory all information presented and collated by the PC-based software. The actual arrangement and content of the stored information may vary considerably, depending on the application, as will be described further below.

The therapy control unit 24 and card receptor 26 may be provided with one or more onboard microprocessors with a general software/firmware operating system installed to provide initial communications capabilities with memory card 32. Information relevant to the operational parameters of the therapeutic means are imported by the therapy control unit 24 and used internally to control any number of individual sub-assemblies of the therapeutic means. In the embodiment illustrated in Figure 1, the therapy control unit 24 can operate the therapy applicator 22 by generating and transmitting the required electrical and/or electromagnetic signals via a cable 21 to the applicator 22. However, in practice the therapy control unit 24, operating in accordance with instructions provided by the memory card 32, may be able to control and manage virtually any automated sub-assemblies or devices that form part of the therapeutic means provided in connection with the support structure 12 of the brace. For example, the therapy control unit 24 may also be used for controlling an automated mechanical sub-assembly for controlling the operation of an adjustable movement restrictor for automatically applying variable amounts of restriction of movement to the knee or other body part. Examples of this type of mechanical sub- assembly will be described further below.

Figure 3 illustrates one possible internal memory layout for a memory card 32. In the illustrated example, the memory card may be provided with identification information 50 for the card issuer, memory card and the designated physiologically active brace. Additional patient ID information 52 may be of a secure encrypted type and require the entry of a PIN prior to device programming. Disorder type information 54 may be desirable for both operational and auditing procedures. CRC and check sum data 56 may be desirable to provide a secure and verifiable means of assuring integrity of the stored information. Therapy information 58 may be serialised by number, contain sequential therapeutic device control instructions, information relating to the programmer and the date and time that the prescribed therapy should be applied. Indeed, any range and type of information may be recorded and stored in the memory card, constrained only by the storage capacity of the memory card and the ability of the therapy control unit 24 to use such information for controlling operation of the device. Card total check sum 60 may also be included, if desired, to enable the system to verify all stored information. Empty or currently unused memory locations 62 may be used for storage of information regarding the operations executed by the device, the type of therapy administered and actual usage dose, rate and time information. Such information may be retrieved later to extract an accurate record of device usage, therapy supplied and any or all other aspects relating to the operation of the physiologically active brace. In this manner, efficacy may be monitored by comparison with such a function log, providing an accurate means of refining and further improving therapy outcomes without the need for supervision, documented notes and other patient management systems.

The physiologically active brace in accordance with the present invention may incorporate a variety of medical electrotherapy devices, including transcutaneous electro-nerve stimulations (TENS) devices, micro-current electrotherapy (MET) devices, neuro- muscular stimulation (NMS) devices, and other similar electrotherapy devices. Such electrotherapy devices typically take advantage of the natural piezo-electric activity of bone, cartilage and tendon material in the human body in response to loads. By mimicking such piezo-electric activity using pulse-width-modulated (P M) digital signals, electrotherapy devices stimulate the human body's own healing processes to produce a therapeutic effect. One example of such a medical therapeutic device which may be incorporated in the brace 10 is a Pulsed Electromagnetic Field (PEMF) therapeutic device. PEMF therapy is a form of electrotherapy used for treating a variety of neuro- muscular injuries, including sports injuries such as persistent rotator-cuff tendonitis. On the basis of a detailed understanding of the underlying pathologies of the medical condition, a suitably qualified therapist can prescribe an appropriate program of PEMF therapy for treatment of the rotator-cuff. The PEMF therapy program may include modulation of the pulse width, pulse frequency, magnitude and other time varying characteristics of a sequentially progressive electromagnetic wave form which is radiated into the affected area by means of therapy applicator 22.

In many other medical conditions it is desirable to administer physiologically active therapy modalities of known type in a sequential and time-organised manner. This is due to the sequential nature of normal tissue reconstruction processes and the manner in which different therapy parameters or modalities stimulate each process differently. For example, in the case of lower tibial fractures, regional vascularity is traditionally low which leads to poor nutrient supply to the osteocytes responsible for production of fracture repair biomaterials. It would therefore be desirable to administer a modality capable of stimulating regional vascularity prior to any other modality. Having provided the means of stimulating nutrient supply, it would then be desirable to administer a therapeutic modality capable of stimulating the osteocyte bio-synthesis. As the modalities or therapy parameters differ in such cases, a means of managing the timed progression from one stimulation mode to the next would be beneficial. For optimum resolution of lower tibial fractures, a third modality capable of stimulating the re-alignment and compaction of newly-synthesised biomaterials would be beneficial. Once again, such stimulation would only be appropriate once the reconstruction process has entered this stage.

Those skilled in the medical arts, will be aware that all musculo-skeletal tissue reconstruction processes follow a specific biological sequence and the ability to stimulate each stage selectively and sequentially would deliver optimum therapeutic outcomes. It is now also understood that reductions in load-bearing stimuli, caused by the use of orthopaedic braces or other support devices, result in tissue loss, atrophy and loss of cellular vigour. The present invention provides the means and method of avoiding this negative aspect of bracing, by facilitating the administration of sequential modalities such as bone and muscle stimulation, which if applied in an event appropriate order, are able to overcome the tissue degeneration usually associated with partial or full immobilisation.

A suitably qualified therapist may use their skill and expertise to design a prescribed therapy program for a particular patient. They may also wish to monitor efficacy against actual device usage in order to better define the therapy program and future applications of the therapy. In this case, a unique identification number may be recorded on the memory card 32 for purposes of identification and therapy auditing. In addition, parameters relating to initial therapy output, number of permissible therapies and duration of each therapy session may be recorded along with a sequentially progressive modification table for purposes of modifying therapy in accordance with therapy progression and/or actual device usage. All such data is recorded and maintained in non-volatile memory on the memory card 32 which may, but not necessarily, be given to the user for home care application, thus reducing institutional administration and management costs.

In use, the memory card 32 is inserted into the therapy card receptor 26 on the brace 10, and the reader software, operating in the control unit 24, may verify the identification codes on the memory card 32 to ensure that the correct card is being used with the correct brace. Once initial safety and security procedures are passed, the therapy control unit can load its instructions from the stored information held on the memory card 32 and verify data integrity via suitable CRC check sum or similar verification methods. In this manner, the physiologically active brace 10 automatically and without intervention, verifies and loads a secure prescription without the need for a therapy designer to have access to the brace or the need to manipulate manual controls. The therapy control unit 24 then executes the prescribed therapy in accordance with internal software rules and may write back to the memory card 32 information relating to actual device usage, output and any other relevant therapy information. In this way, the brace uses the memory card 32 as a non-volatile record of all actions for later use, retrieval and inspection. If deemed desirable, the brace may employ certain data sectors, stored on the memory card and modified in accordance with actual usage, to possibly modify the therapy output in accordance with programmed rules in order to provide a sequentially progressive therapy without manual intervention, supervision or the need to make adjustments to controls. Advantageously, memory card 32 may include a decremental counter which sets an expiry date for the card after a prescribed time duration or number of therapy sessions.

At the end of a therapy program, the information relating to actual brace usage recorded on the memory card 32 by the therapy control unit 24, may be readily and conveniently transported to a suitable location for later retrieval for comparison with actual gained efficacy. If desired, the memory card 32 can be interrogated on-line, if the user is provided with a suitable card read/write device similar to the device 30 illustrated in Figure 2 for connection to their home PC. The memory card 32 thereby provides an accurate, convenient and effective means of further refining therapy type, duration and number of sessions based on accurate usage information. Further or revised electronic prescriptions can be downloaded onto the memory card 32 based on an evaluation of the progress of the therapy to date.

As noted above, a physiologically active brace in accordance with the present invention may also incorporate one or more mechanical sub-assemblies for automatically applying variable amounts of restriction or assistance of movement to a body part. For example, the brace may be provided with a movement restrictor in the form of a tensioner for varying the tension applied to a hinge of the brace. In such a case, the brace can provide a means of applying sequentially increasing mechanical resistance by the sequential addition of small amounts of additional tension to the hinge in order to administer and manage a sequential physical rehabilitation program without manual intervention. Figures 4 to 6 illustrate three possible embodiments of a sequentially progressive hinge that can be employed in a physiologically active brace in accordance with the present invention.

An orthopaedic hinge with variable resistance provides a means by which the amount and extent of physical load to the musculo-tendinous, osteo-tendinous and other cellular structures can be controlled. It is generally known by those skilled in the medical arts that physical loading plays an important role in tissue recovery processes. It is further known that the biosynthesis rates of certain cellular structures are influenced significantly by physical loading. The injured part can be readily re-injured if force is applied excessively or to early in the recovery process. As injury recovery is an extended process lasting upwards of 12 months and involving many different cellular phases, each requiring optimum stimulation and management, it is desirable to provide a means of providing such stimulation and management in the form of an automated wearable system able to be used without close supervision.

In one form of the present invention, the physiologically active brace is provided with an orthopaedic hinge fitted with a means of automatically adjusting hinge resistance in a sequential and variable manner against a predefined or calculated protocol. In this manner, the rate and type of biosynthesis can be optimised in accordance with the changing physiological processes involved. For example, physical loading could be kept to a minimum during the first five days of the vascular phase, then increased logorithmetically during the following 11 day cellular phase to encourage biosynthesis, cellular alignment and to reduce scarring. In this manner, complex sequential protocols can be created to optimise injury recovery in a large range of disorders, age groups and fitness levels.

Figure 4 illustrates one possible embodiment of a sequentially progressive hinge 34 that can be employed in a physiologically active brace in accordance with the invention. The hinge 34 is fitted with a means for applying variable resistance to pivoting movement of the hinge. In this case, a pneumatic or hydraulic ram 36 is employed to apply resistance to pivoting movement of the hinge. Ram 36 is fitted with a small electric worm drive 38 or similar electromechanical actuator for adjusting the entry, release or circulation of gas or other fluid within the cylinder of the ram 36. Worm drive 38 may be operatively connected to the sequential therapy control unit 34 of the brace, and can be used to incrementally adjust the position of, for example, a needle valve or similar flow control means for controlling the free flow of fluid into or out of the cylinder. Thus, for example, at a first minimum resistance setting, the needle valve is set to the fully open position providing minimum flow resistance and allowing the free movement of the hinge. As and when required, the worm drive is driven incrementally under the control of therapy control unit 24 and in accordance with predetermined control instructions as recorded in memory card 32, to wind in the needle valve and incrementally adjust the restriction of flow and produce a corresponding increase in resistance to pivoting movement of the hinge. In this manner, the direction, period and extent of resistance may be readily controlled and automatically adjusted.

Figure 5 illustrates a second embodiment of a sequentially progressive hinge 40 in which a peristaltic tube 42 passes between a plurality of compression rollers 44. An electromechanical actuator 46 is used to control fluid flow within the tube 42 and thereby provide variable resistance to pivoting movement of the hinge 40. As in the previous embodiment, electromechanical actuator 46 is used to restrict fluid flow within the tube 42 and thereby provide variable resistance to pivoting movement of the hinge 40. As in the previous embodiment, electromechanical actuator 46 is operatively connected to and under the control of an electronic control means provided in connection with the support structure of the brace, similar to sequential therapy control unit 24 of the brace illustrated in Figure 1. In this embodiment, fluid is forced through the tube 42 by pivoting movement of the hinge element. The electrically controlled fluid flow restrictor may be set to a minimum value to allow free pivoting movement or a maximum value to provide near total restriction of hinge movement.

Figure 6 illustrates a still further embodiment of a sequentially progressive hinge 64 which may be incorporated in the physiologically active brace of the invention. In this case, frictional resistance is used to control hinge resistance. A small electromechanical worm drive or similar actuator is used to either reduce or expand the diameter of a central void 66 provided at an end of one of the hinge elements, and within which a boss 68 provided on an end of the other hinge element is pivotally received. Driving the electromechanical worm drive 65 to a minimum value opens the void thus allowing free pivoting movement of the hinge, whereas incrementally driving the worm drive 65 to a maximum value progressively reduces the diameter of the void 66 and increases the frictional resistance to pivoting movement of the hinge 64.

Now that several embodiments of the physiologically active brace and method of physiologically active bracing have been described in detail, numerous advantages will be apparent, including the following:

(i) it provides a simple and convenient means of programming and automatically administering an "electronic prescription" without the need for manual intervention;

(ii) it facilitates an entire rehabilitation program or wearable rehabilitation "process" by the addition of sequential therapeutic influences to the biomechanical properties of a brace;

(iii) it allows optimum therapeutic outcomes to be gained without the usual negative aspects of bracing;

(iv) it allows suitably qualified people to control and administer the delivery of a prescribed therapy without the need to have direct access to the brace;

(v) it provides means of monitoring patient compliance with a therapy program and measuring the efficacy of the therapy program;

(vi) it facilitates the development of custom-designed protocols, have them run automatically, provide an audit of actual usage and allow modifications to the prescription by taking feedback from the brace;

(vii) it enables the brace to be programmed to automatically adjust working parameters in accordance with other pre-determined rules and/or actual device usage and patient response to the therapy;

(viii) it provides a secure means of electronic prescription, allowing therapeutic regimes to be refined and improved more expeditiously;

(ix) it frees up doctors, nursing staff and other health care professionals to attend to less mundane tasks and devote their time to a greater number of patients.

Numerous variations and modifications will suggest themselves to persons skilled in the biomedical engineering arts, in addition to those already described, without departing from the basic inventive concepts. For example, any other suitable removable nonvolatile information storage medium may be employed apart from the memory cards of the illustrated embodiment, such as a magnetic storage card. Whilst the physiologically active brace has been described primarily in its application to medical therapies, it is to be understood that it also has wider application, for example, in the area of sports therapy for treating sports injuries or enhancing athletic performance. All such variations and modifications are to be considered within the scope of the present invention, the nature of which is to be determined from the foregoing description.

Claims

The claims defining the invention are as follows:

1. A physiologically active brace comprising: a mechanical support structure adapted to be worn by a user in connection with a part of the body ; therapeutic means mounted on said support structure for applying a prescribed therapy for a user to said body part; a therapy control unit for automatically controlling operation of the therapeutic means, the therapy control unit being responsive to predetermined control instructions derived from the prescribed therapy for the user; and a storage medium reading device operatively connected to said therapy control unit, said reading device being arranged to receive a removable nonvolatile information storage medium on which is stored said predetermined control instructions, and to read said predetermined control instructions from said storage medium; wherein, in use, the therapy control unit receives said predetermined control instructions from said storage medium and said therapeutic means applies the prescribed therapy without the need for close human supervision.

2. A brace as claimed in Claim 1, wherein the therapeutic means includes an electrotherapy device arranged to generate electrical and/or electromagnetic signals under control of the therapy control unit to stimulate the human body's healing processes to thereby produce a therapeutic effect.

3. A brace as claimed in Claim 2, wherein the electrotherapy device includes a therapy applicator for applying said electrical and/or electromagnetic signals during use through the skin of a user to a predetermined part of the user's body.

4. A brace as claimed in Claim 2 or Claim 3, wherein the electrotherapy device is a transcutaneous electro-nerve stimulation (TENS) device, a micro-current electrotherapy (MET) device, a neuro-muscular stimulation (NMS) device, or a pulsed electromagnetic field (PEMF) device.

5. A brace as claimed in Claim 1, wherein the therapeutic device includes an adjustable movement restrictor for applying variable amounts of restriction of movement to said body part under control of the therapy control unit to thereby produce a therapeutic effect.

6. A brace as claimed in Claim 5, wherein said brace includes a hinge, said movement restrictor is a tensioner arranged to variably apply tension to the hinge, and said prescribed therapy includes predetermined sequential addition of tension to the hinge to thereby stimulate tissue growth.

7. A brace as claimed in Claim 6, wherein the adjustable movement restrictor includes a pneumatic or hydraulic ram and an activator for adjusting flow of fluid to and from a cylinder of the ram.

8. A brace as claimed in Claim 6, wherein the adjustable movement restrictor includes a plurality of compression rollers, a peristaltic tube passing between the compression rollers and an actuator for adjusting flow of fluid to and from the peristaltic tube.

9. A brace as claimed in Claim 6, wherein the adjustable movement restrictor includes a boss provided on a first hinge element, a void defined by a second hinge element and arranged to receive the boss, and an actuator for increasing or reducing the diameter of the void so as to thereby increase or reduce friction between the first and second hinge elements.

10. A brace as claimed in any one of the preceding claims, wherein said therapy control unit is arranged to control said therapeutic means according to a prescribed sequence of therapy.

11. A brace as claimed in Claim 10, wherein said predetermined control instructions include instructions for carrying out a series of sequential and/or timed events.

12. A brace as claimed in any one of the preceding claims, wherein said storage medium reading device is a memory card reading device.

13. A brace as claimed in any one of the preceding claims, wherein said storage medium reading device is arranged to write information to a storage medium.

14. A brace as claimed in any one of the preceding claims, wherein the mechanical support structure is adapted to be worn by a user in connection with a knee.

15. A method of physiologically active bracing, said method comprising the steps of: providing a mechanical support structure adapted to be worn by a user in connection with a part of the body; providing therapeutic means mounted on said support structure for applying a prescribed therapy for the user to said body part; providing a therapy control unit for automatically controlling operation of the therapeutic means, the therapy control unit being responsive to predetermined control instructions derived from the prescribed therapy for the user; programming a portable non-volatile information storage medium with the predetermined control instructions; and supplying the programmed information storage medium to a user for insertion in a storage medium reading device operatively connected to said therapeutic means; wherein, in use, the therapeutic control unit receives said predetermined control instructions from said storage medium and said therapeutic means applies said prescribed therapy without the need for close human supervision.

16. A method as claimed in Claim 15, wherein the therapeutic means includes an electrotherapy device arranged to generate electrical and or electromagnetic signals under control of the therapy control unit to stimulate the human body's healing processes to thereby produce a therapeutic effect.

17. A method as claimed in Claim 15, wherein the therapeutic means includes an adjustable movement restrictor for applying variable amounts of restriction of movement to said body part under control of the therapy control unit to thereby produce a therapeutic effect.

18. A method as claimed in any one of Claims 15 to 17, wherein said predetermined control instructions include instructions indicative of therapy application rates, permitted frequency of therapy application and/or the timing of each application of therapy.

19. A method as claimed in any one of Claims 15 to 18, further including the step of programming the information storage medium with identification information relating to a particular user, to the information storage medium and to a designated physiologically active brace, wherein only an identified user can use the information storage medium in the designated physiologically active brace.

20. A method as claimed in Claim 19, wherein said step of programming the information storage medium is carried out on-line by downloading said predetermined control instructions.