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Sponsors and Collaborators: |
University of Alberta International Spinal Research Trust Alberta Heritage Foundation for Medical Research |
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Information provided by: | University of Alberta |
ClinicalTrials.gov Identifier: | NCT00656149 |
Hypotheses:
Condition | Intervention | Phase |
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Spinal Cord Injury Quadriplegia Tetraplegia |
Behavioral: FES-assisted In-home telerehabilitation of hand function Behavioral: Exercise training |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Outcome Evaluation of Exercise and Electrical Therapy for Quadriplegic Hand Function |
Estimated Enrollment: | 20 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
FES-assisted hand exercises on a workstation.
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Behavioral: FES-assisted In-home telerehabilitation of hand function
6 weeks, 1 hr/day FES-assisted exercise therapy on a workstation, supervised over the Internet.
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2: Active Comparator
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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Behavioral: Exercise training
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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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Su Ling Chong, PT | +17804921616 | slchong@ualberta.ca |
Contact: Arthur Prochazka, PhD | +17804923783 | arthur.prochazka@ualberta.ca |
Canada, Alberta | |
Centre for Neuroscience, University of Alberta | Recruiting |
Edmonton, Alberta, Canada, T6C1M8 | |
Contact: Su Ling Chong, PT +17804921616 slchong@ualberta.ca | |
Contact: Artuhr Prochazka, PhD +17804923783 arthur.prochazka@ualberta.ca | |
Principal Investigator: Arthur Prochazka |
Principal Investigator: | Arthur Prochazka | University of Alberta |
Responsible Party: | University of Alberta ( Arthur Prochazka ) |
Study ID Numbers: | SCI-IHT, ISRT-G700000249 PY107 |
Study First Received: | April 1, 2008 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00656149 |
Health Authority: | Canada: Health Canada |
telerehabilitation functional electrical stimulation spinal cord injury hand function rehabilitation |
Paralysis Signs and Symptoms Spinal Cord Injuries Spinal Cord Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Neurologic Manifestations Trauma, Nervous System Quadriplegia |
Nervous System Diseases |