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| ID | Type | Description | Link |
|---|---|---|---|
| ISRT-G700000249 PY107 |
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| Name | Class |
|---|---|
| International Spinal Research Trust | OTHER |
| Alberta Heritage Foundation for Medical Research | OTHER |
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Hypotheses:
Chronic C5, 6 or 7 SCI subjects who have sustained a cervical SCI resulting in complete or incomplete quadriplegia. Time since injury at least one year at time of entry to study. Subjects may have a complete or an incomplete injury but must demonstrate loss of finger grasp and release as well as loss of thumb lateral (key) pinch bilaterally or unilaterally. Subjects must be stable neurologically and medically, cognitively intact, and willing and able to attend the requisite appointments for participation in the study.
Two treatments, each delivered 1 hour per day, five days a week over six weeks are given in a randomized order.
Treatment A
Subjects perform 1 hour per day of FES-assisted hand exercises on an instrumented exercise workstation in their homes, supervised remotely over the Internet. Four manipulanda in the workstation are used per exercise session. Each manipulandum is an object such as a spring-loaded doorknob, representing a task of daily life. As their motor skills improve over consecutive sessions, subjects are presented with manipulanda of increasing difficulty. A muscle stimulator garment is provided to each subject for FES-assisted exercise (Prochazka et al. 1997b). Hand opening and closing are wirelessly triggered from an earpiece that detects small voluntary tooth-clicks. The stimulator system is CSA-approved.
Treatment B Subjects perform the following tasks 1 hour per day in their homes, supervised remotely over the Internet.
The outcome measures are tested at 2-week intervals and require visits to the Center for Neuroscience at the University of Alberta. A maximum of CDN$2,000 is available to reimburse participants' travel and accommodation costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telerehabilitation of hand function | Active Comparator | Intervention: for one hour per day participants perform exercise therapy on a home-based tele-rehabilitation workstation, the Rehabilitation Joystick for Computerized Exercise (ReJoyce) with which participants play computer games associated with activities of daily life. A remote therapist coaches each one-hour session over the Internet, with the use of the ReJoyce tele-rehabilitation system. Hand grasp-release is assisted with functional electrical stimulation (FES) triggered voluntarily by the participant with the use of a wireless earpiece with a sensor that detects toothclicks. |
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| Conventional exercise therapy | Active Comparator | Intervention: for one hour per day participants perform conventional range-of-motion tasks with a wristlet weight (20 min), precision tasks with a computer mouse (20 min) and receive cyclical electrical stimulation of hand muscles (20 with the use of the ReJoyce tele-rehabilitation min). A remote therapist coaches each one-hour session A remote therapist coaches each one-hour session over the Internet, with the use of the ReJoyce tele-rehabilitation system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation of hand function | Procedure | 6 weeks, 1 hr/day FES-assisted exercise therapy on a workstation, supervised over the Internet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Action Research Arm Test | every 2 weeks during therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Transcranial magnetic stimulation | every 2 weeks during therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur Prochazka | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Neuroscience, University of Alberta | Edmonton | Alberta | T6C1M8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21372246 | Result | Kowalczewski J, Chong SL, Galea M, Prochazka A. In-home tele-rehabilitation improves tetraplegic hand function. Neurorehabil Neural Repair. 2011 Jun;25(5):412-22. doi: 10.1177/1545968310394869. Epub 2011 Mar 3. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D011782 | Quadriplegia |
| 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 |
|---|---|
| D004599 | Electric Stimulation Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Conventional exercise therapy | Procedure | For one hour per day subjects perform range-of-motion tasks with a wristlet weight (20 min), precision tasks with a computer mouse (20 min) and receive cyclical electrical stimulation of hand muscles (20 min). |
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| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |