Centre for Neuroscience, University of Alberta
Edmonton, Alberta, T6C1M8, Canada
NCT Number: NCT00656149
1. To evaluate improvements in hand function in stable, cervical spinal cord injured (SCI) subjects treated with functional electrical stimulation (FES)-assisted exercise; 2. To compare the information obtained from existing qualitative and quantitative hand function tests with newly developed tests of sensorimotor performance.
Hypotheses:
1. the performance of tasks representative of activities of daily living (ADL) will improve with daily tele-supervised exercise of the affected hand. 2. The improvements will be greater in one exercise protocol than the other, the protocols being a) FES-assisted exercise on a workstation, b) cyclical FES, weight training and precision tasks. 3. Scores derived from quantitative data obtained from sensors on the workstation will correlate with the qualitative scores of the primary outcome measure, the ARAT hand function test.
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Edmonton, Alberta, T6C1M8, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
6 weeks, 1 hr/day FES-assisted exercise therapy on a workstation, supervised over the Internet.
Other names: In-home telerehabilitation, Functional electrical stimulation (FES), Intensive exercise therapy, Massed practice
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).
Other names: In-home telerehabilitation, Therapeutic electrical stimulation (TES), Intensive exercise therapy, Massed practice
Time frame: every 2 weeks during therapy
Time frame: every 2 weeks during therapy
University of Alberta
Other
Outcome Evaluation of Exercise and Electrical Therapy for Quadriplegic Hand Function
Acronym: SCI-IHT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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