None listed
Conditions
Brief summary
The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with tetraplegia (a spinal cord injury). A total of 78 participants will be randomised into two groups; 1. the experimental group and 2. the control group. The control group will receive standard rehabilitation care, while the experimental group will receive standard rehabilitation care plus the study treatment which involves one hour of extra hand training using a specialised glove and computer workstation, 5 times a week. The primary objective is to determine if the study treatment is more effective than standard rehabilitation care alone in participants with tetraplegia. The secondary objectives involve collecting exploratory data to support primary objective, including an economic analysis. Total study duration is 3 years, including an 18 month recruitment period, an 8-week treatment period followed by 6 month and 12 month follow up assessments. The study treatment will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy/occupational therapy assessments which involve grasping and releasing different objects and performing everyday tasks as well as quality of life questionnaires. Functional electrical stimulation combined with task-specific training provided in addition to standard care is more effective in improving hand function than standard care alone.
Interventions
The device is a muscle-stimulator garment that incorporates a wireless-triggered stimulator cuff which emitts electrical impulses known as Functional Electrical Stimulation (FES). The garment is worn on the forearm and triggered when the user clicks his/her teeth. The tooth clicks (vibrations) are detected by an earpiece, similar to a hearing aid, that sends a radio signal to the stimulator cuff. This in turn stimulates the hand to open or close, allowing the patients to grasp and release object
The device is a muscle-stimulator garment that incorporates a wireless-triggered stimulator cuff which emitts electrical impulses known as Functional Electrical Stimulation (FES). The garment is worn on the forearm and triggered when the user clicks his/her teeth. The tooth clicks (vibrations) are detected by an earpiece, similar to a hearing aid, that sends a radio signal to the stimulator cuff. This in turn stimulates the hand to open or close, allowing the patients to grasp and release objects. The garmet will be used five times a week for up to one hour each session, over the 8 week intervention period. Patients will continue to receive standard care while participating in the study. The study intervention will be in addition to standard care. The stimulator system has been approved by the Canadian Standards Association. The device is not yet available in Australia, but will be obtained from the inventor, Professor Arthur Prochazka, University of Alberta, Canada when funding for the study becomes available.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* have sustained a Spinal Cord Injury (SCI)within the preceding 6 months from time of consent * are currently receiving inpatient rehabilitation through one of the study sites * will remain in hospital for 12 weeks after initial screening * are 16 years of age or older and able to provide informed consent * have a motor complete or incomplete spinal cord injury at the neurological level of C2 to T1 (as per the International Standardised Neurological Assessment for SCI) * can actively flex their target shoulder to 60 degrees * have reduced ability to grasp using the target hand * are able to tolerate sufficient Functional Electrical Stimulation (FES) to enable one hand to grasp and release * have the potential to benefit from FES and ReJoyce according to the judgment of the treating therapist
Exclusion criteria
* have any other type of neurological injury affecting the target hand (e.g. brachial plexus or peripheral nerve injuries) * have had recent trauma or surgery to the target hand or upper limb within the last 12 months * have had amputation of any digits on the target hand * are not able to sit out of bed each day for at least 2 hours over three consecutive days * have extensive fixed contractures in the upper limb of the target hand preventing use of the ReJoyce * have severe spasticity in the target hand or upper limb preventing use of the ReJoyce * are unable to attend the 6-month and 1-year follow-up assessments at their treating spinal unit * are likely to undergo hand surgery in the target hand in the next year * are likely to experience autonomic dysreflexia and/or hypotension in response to electrical stimulation * have any contraindications to FES such as cardiac pacemaker, epilepsy, forearm fracture or pregnancy * have intracranial metal implants * have impaired vision and/or are unable to view a computer screen * have any other serious medical condition including malignancies, psychiatric, behavioural or drug-dependency problems, which are likely to influence the participant’s ability to cooperate or in the opinion of the study investigator would prevent the participant from adhering to the Protocol.
Outcome results
None listed