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| Name | Class |
|---|---|
| Austin Hospital, Melbourne Australia | OTHER |
| Hampstead Rehabilitation Centre Adelaide | UNKNOWN |
| Shenton Park Rehabilitation Centre Perth | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | In addition to standard care participants in Group A will receive: • One hour of extra hand training five times per week for 8 weeks using the ReJoyce Workstation. The training will be supervised by a therapist and provided to the target hand. The hand exercises will be incorporated into computer games and will involve the following tasks using different manipulanda:
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| Standard Care Group | Other | Participants in the control group will not receive any training on the instrumented workstation or electrical stimulation to the hand or upper limb. They will however continue to receive standard care as well as three 15-minute specific hand activity sessions per week specifically devoted to the practice of hand activities in a one-to-one format with a therapist (as per the treatment received by the experimental group). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReJoyce Workstation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Action Research Arm Test | A standardized measure of unilateral hand and upper limb function | 8 weeks and 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Summed Upper Limb Strength of the Graded and Redefined Assessment of Strength Sensibility and Prehension | Summed strength score of 10 upper limb muscles | 8 weeks and 26 weeks |
| Sensory Score on ISNCSCI |
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Inclusion Criteria:
Patients will be included if they:
Exclusion Criteria:
Patients will not be included if they:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Harvey | University of Sydney | Principal Investigator |
| Mary Galea | University of Melbourne | Principal Investigator |
| Sarah Dunlop | The University of Western Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spinal Unit, Prince of Wales Hospital | Randwick | New South Wales | Australia | |||
| Royal Rehabilitation Centre Sydney |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21235821 | Background | Harvey LA, Dunlop SA, Churilov L, Hsueh YS, Galea MP. Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial. Trials. 2011 Jan 17;12:14. doi: 10.1186/1745-6215-12-14. | |
| 27008910 | Result | Harvey LA, Dunlop SA, Churilov L, Galea MP; Spinal Cord Injury Physical Activity (SCIPA) Hands On Trial Collaborators. Early intensive hand rehabilitation is not more effective than usual care plus one-to-one hand therapy in people with sub-acute spinal cord injury ('Hands On'): a randomised trial. J Physiother. 2016 Apr;62(2):88-95. doi: 10.1016/j.jphys.2016.02.013. Epub 2016 Mar 19. |
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Data will only be provided in aggregate. No individual data will be released, as per the ethics approval.
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Princess Alexandra Hospital, Brisbane, Australia |
| OTHER |
| Royal Rehabilitation Centre Sydney | UNKNOWN |
| Prince of Wales Hospital, Sydney | OTHER_GOV |
| Burwood Hospital, Christchurch, New Zealand | OTHER |
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| Standard Care | Other | All participants will continue to receive the same standard care for the hand and upper limb as typically provided by their rehabilitation units. |
|
Scores for light touch and pinprick tested in dermatomes of the upper limb
| 8 weeks and 26 weeks |
| AsTex Sensory Test | A measure of texture discrimination in the fingertips | 8 weeks and 26 weeks |
| AuSpinal Test | A test of hand function | 8 weeks and 26 weeks |
| Capabilities of Upper Extremity | A questionnaire about upper limb function | 8 weeks and 26 weeks |
| Assessment of Quality of Life (AQoL) | A questionnaire to assess quality of life | 8 weeks and 26 weeks |
| Health Utilities Index Mark 3 | A questionnaire to assess quality of life, but includes a domain on hand function | 8 weeks and 24 weeks |
| Self-care subscale of the Spinal Cord Independence Measure | A questionnaire about independence in self-care | 8 weeks and 24 weeks |
| Goal Attainment Scale | An assessment of whether a participant achieved pre-set goals | 8 weeks |
| Participant Perception of Treatment Effectiveness | Self resport of treatment effectiveness | 8 weeks |
| Sydney |
| New South Wales |
| Australia |
| Queensland Spinal Cord Injury Service, Princess Alexandra Hospital | Woolloongabba | Queensland | Australia |
| South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre | Northfield | South Australia | Australia |
| Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre | Kew | Victoria | 3101 | Australia |
| Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital | Shenton Park | Western Australia | Australia |
| Burwood Academy | Christchurch | New Zealand |
| 28970100 | Derived | Harvey LA, Dunlop SA, Churilov L, Galea MP; Spinal Cord Injury Physical Activity (SCIPA) Hands On Trial Collaborators. Early intensive hand rehabilitation is not more effective than usual care plus one-to-one hand therapy in people with sub-acute spinal cord injury ('Hands On'): a randomised trial. J Physiother. 2017 Oct;63(4):197-204. doi: 10.1016/j.jphys.2017.08.005. Epub 2017 Sep 29. |
| D014947 | Wounds and Injuries |