Spinal Cord Injury Clinical Trial
Official title:
Effect of Prolonged Electrical Stimulation on Neural Plasticity in SCI
Electrical stimulation (pulses of electricity applied over the skin of your wrist) and activity-based hand exercise have been shown to improve motor skill and strength in individuals with stroke and have recently been shown to also have an effect on individuals with spinal cord injury. Therefore, the purpose of this research study is to investigate whether electrical stimulation alone or electrical stimulation followed by activity-based training produces gains in pinch strength (how hard you can squeeze your thumb and pointer finger together) and upper extremity function (how well your arm and hand can perform activities) in individuals with spinal cord injury.
Status | Completed |
Enrollment | 36 |
Est. completion date | June 2011 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Trace voluntary thumb movement or able to pick up small objects with a tenodesis grip - Between ages 18 and 60 - Spastic paresis (manifest as spasms, clonus, and/or hyperreflexia) due to neurologically incomplete SCI - Medically stable - Communicate questions/needs and answer yes/no questions reliably. Exclusion Criteria: - Altered cognitive status - Level of injury caudal to the C7 level - History of CVA, seizures - Implanted metal devices in the head, less than one year post injury, and severe spasticity of the muscles of the upper extremities (defined by a score of 2 or higher on the Modified Ashworth Spasticity Scale) - Patients with pacemakers will also be excluded from this study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | VA Medical Center, Miami | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Conduct pre-and post-training assessments of behavioral outcomes using Wolf Motor Function Test and Jebsen Taylor Hand Function test to measure upper extremity function, hand-held dynamometry to measure pinch grip strength, and Semmes-Weinstein Monofilam | Outcome measures: baseline, 6 weeks after baseline, post testing, 6 weeks post testing | No |
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