Spinal Cord Injury
Conditions
Brief summary
Loss of hand function is one of the most devastating consequences of tetraplegia because of the severe impact on activities of daily living (ADL) and the resultant dependency on others. This multi-centre study in 78 participants will measure whether additional hand therapy provided via an electrical stimulator glove and specialised computer workstation improves hand function in people with tetraplegia.
Detailed description
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 their standard rehabilitation care, while the experimental group will receive the standard rehabilitation care plus the study treatment. The study treatment will consist of one hour of extra hand training, 5 times a week, using a specialised glove which provides electrical impulses to the patient's hand allowing them to open and close their hand. The glove will be used to play games on a specialised computer workstation which focuses on hand movement and function. The main objective of this study is to determine if the experimental treatment is more effective than standard rehabilitation care alone in participants with tetraplegia. 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 progress of the participant's therapy during the study will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy and occupational therapy assessments which focus on hand function. These involve grasping and releasing different everyday objects and performing everyday tasks as well as quality of life questionnaires.
Interventions
OTHERStandard Care
All participants will continue to receive the same standard care for the hand and upper limb as typically provided by their rehabilitation units.
DEVICEReJoyce Workstation
The device has two parts. A muscle-stimulator garment that incorporates a wireless-triggered stimulator cuff and an earpiece, similar to a hearing aid, that sends a radio signal to the stimulator cuff. As well as a specialised workstation known as ReJoyce, which connects to a standard computer via a USB port. This work station will allow the user to play specialised computer games focusing on hand function. The stimulator system and the ReJoyce workstation were developed by Professor Arthur Prochazka, University of Alberta, Canada and has been approved by the Canadian Standards Association.
Sponsors
Austin Hospital, Melbourne Australia
Hampstead Rehabilitation Centre Adelaide
Shenton Park Rehabilitation Centre Perth
Princess Alexandra Hospital, Brisbane, Australia
Royal Rehabilitation Centre Sydney
Prince of Wales Hospital, Sydney
Burwood Hospital, Christchurch, New Zealand
University of Melbourne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients will be included if they: 1. have sustained a SCI within the preceding 6 months from time of consent 2. are currently receiving inpatient rehabilitation through one of the study sites 3. will remain in hospital for 12 weeks after initial screening as part of their standard medical/rehabilitation care 4. are 16 years of age or older and able to provide informed consent 5. 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) 6. can actively flex their shoulder/s to 60 degrees 7. have reduced ability to grasp using their hands 8. are able to tolerate sufficient FES to enable one hand to grasp and release 9. have the potential to benefit from FES and ReJoyce according to the judgment of the treating therapist
Exclusion criteria
Patients will not be included if they: 1. have any other type of neurological injury affecting the target hand (e.g. brachial plexus or peripheral nerve injuries) 2. have had recent trauma or surgery to the target hand or upper limb within the last 12 months 3. have had amputation of any digits on the target hand 4. are not able to sit out of bed each day for at least 2 hours over three consecutive days 5. have extensive fixed contractures in the upper limb of the target hand preventing use of the ReJoyce 6. have severe spasticity in the target hand or upper limb preventing use of the ReJoyce 7. are unable to attend the 6-month and 1-year follow-up assessments at their treating spinal unit 8. are likely to undergo hand surgery in the target hand in the next year 9. might experience autonomic dysreflexia and/or hypotension in response to electrical stimulation 10. have any contraindications to FES, such as cardiac pacemaker, epilepsy, forearm fracture or pregnancy 11. have intracranial metal implants 12. have impaired vision and/or are unable to view a computer screen 13. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Action Research Arm Test | 8 weeks and 26 weeks | A standardized measure of unilateral hand and upper limb function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensory Score on ISNCSCI | 8 weeks and 26 weeks | Scores for light touch and pinprick tested in dermatomes of the upper limb |
| AsTex Sensory Test | 8 weeks and 26 weeks | A measure of texture discrimination in the fingertips |
| AuSpinal Test | 8 weeks and 26 weeks | A test of hand function |
| Capabilities of Upper Extremity | 8 weeks and 26 weeks | A questionnaire about upper limb function |
| Summed Upper Limb Strength of the Graded and Redefined Assessment of Strength Sensibility and Prehension | 8 weeks and 26 weeks | Summed strength score of 10 upper limb muscles |
| Health Utilities Index Mark 3 | 8 weeks and 24 weeks | A questionnaire to assess quality of life, but includes a domain on hand function |
| Self-care subscale of the Spinal Cord Independence Measure | 8 weeks and 24 weeks | A questionnaire about independence in self-care |
| Goal Attainment Scale | 8 weeks | An assessment of whether a participant achieved pre-set goals |
| Participant Perception of Treatment Effectiveness | 8 weeks | Self resport of treatment effectiveness |
| Assessment of Quality of Life (AQoL) | 8 weeks and 26 weeks | A questionnaire to assess quality of life |
Countries
Australia, New Zealand
Outcome results
None listed