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Sponsors and Collaborators: |
University of Pittsburgh Allergan |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00462449 |
FES is a form of treatment with a device to aid movement in people who have had damage to their brain or spinal cord. Small electrical impulses are used to excite/stimulate the nerves that supply paralyzed muscles. This activates those muscles, enabling them to produce basic but useful movement. Self-adhesive patches (electrodes) are placed on the skin close to the nerve that supplies the muscle and are connected by wires to a stimulator that produces the impulses. In this way, FES is used to correct the muscle weakness that is caused by injury to the brain or spinal cord.
Repetitive task practice is an "activity-based" therapy program that has been shown to enhance the recovery of hand and arm functions after stroke. This therapy consists of a set of training activities that are designed by a qualified therapist specific to your functional abilities that are to be performed with the impaired hand. These activities are designed to stimulate functional improvement with repetitive practice.
Spasticity is a nervous system disorder where certain muscles are continuously contracted. Botox injections are commonly used to help to reduce spasticity in areas of the body with increased muscle tone. This research is designed to look at any additional benefit that may occur when Botox injections are combined with specific occupational therapy exercises and with a device that uses functional electrical stimulation (FES) to help improve muscle function after stroke.
Condition | Intervention |
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Upper Extremity Spasticity Stroke Acquired Brain Injury |
Device: Functional Electrical Stimulation (FES) through the Ness H200 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Single Blind, Randomized Study to Determine the Safety and the Efficacy of Using Functional Electrical Stimulation (FES) and Repetitive Task Practice vs. Repetitive Task Practice Alone in Persons Receiving Botulinum Neurotoxin Type A Injections for Upper Extremity Spasticity |
Estimated Enrollment: | 48 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Individuals randomized into this group will only receive specialized therapy associated with this population.
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2: Experimental
In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
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Device: Functional Electrical Stimulation (FES) through the Ness H200
Specialized exercises will be presented to the participants in this group. They will be instructed on how to attach and complete this exercise program utilizing the FES device.
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This is a single-blinded, randomized controlled trial examining the effect of repetitive task practice (RTP) and functional electrical stimulation (FES) in individuals who receive routine clinical Botox ® injections for upper extremity spasticity. Botox® injections in combination with repetitive task practice (RTP) is used routinely to manage upper limb spasticity after stroke or acquired brain injury. RTP is an activity-based rehabilitation program that has been shown effective in promoting motor recovery (Wolf et al., 2002), but it requires a sufficient level of baseline motor function. Since FES enhances motor function, we hypothesize that an FES-assisted RTP intervention will provide greater improvement in hand function than RTP alone in patients receiving Botox ® injections.
The primary outcome will be upper extremity use during activities of daily living assessed observationally by the motor activities log (MAL-O). Secondary outcomes will be 1) dexterous hand function as measured by the action research arm test (ARAT); 2) client's perception of self-performance in activities of daily living assessed with the (MAL - Self Report); 3) global upper extremity impairment assessed by the Chedoke-McMaster Assessment (CMA); and 4) clinical spasticity assessed by the Modified Ashworth Scale (MAS).
The primary endpoint will be 6 weeks post-injection. Outcomes will also be assessed at a secondary endpoint, 12 weeks post-injection, to determine the persistence of treatment effects.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christine L. Harrison, BS | 412-586-6927 | harrisonta@upmc.edu |
Contact: Cierra X. Jenkins | 412-648-6666 | jenkinscx@upmc.edu |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Christine L. Harrison, BS 412-586-6927 harrisonta@upmc.edu | |
Contact: Cierra X. Jenkins 412-648-6666 jenkinscx@upmc.edu | |
Sub-Investigator: Elizabeth R. Skidmore, PhD, OTR/L | |
Sub-Investigator: Douglas Weber, PhD | |
Principal Investigator: Michael C. Munin, M.D. | |
Sub-Investigator: Lynn M. Huber, OTR/L | |
Sub-Investigator: Ross D. Zafonte, D.O. | |
Sub-Investigator: Christine L. Harrison, BS |
Principal Investigator: | Michael C. Munin, M.D. | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( Michael C. Munin, M.D. ) |
Study ID Numbers: | 0611012 |
Study First Received: | April 17, 2007 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00462449 |
Health Authority: | United States: Institutional Review Board |
Botulinum Toxin Ness H200 Functional Electrical Stimulation Repetitive Task Practice |
Craniocerebral Trauma Cerebral Infarction Stroke Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System Brain Diseases |
Signs and Symptoms Muscle Spasticity Botulinum Toxins Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neurologic Manifestations Brain Injuries |
Neuromuscular Manifestations Nervous System Diseases |