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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00142792 |
Stroke is the leading cause of activity limitation among older adults in the United States. NeuroMuscular Electrical Stimulation (NMES) can assist stroke survivors in regaining motor ability and decreasing activity limitation caused by stroke. This study will research the effects of two types of NMES on reducing motor impairment and activity limitation.
Condition | Intervention | Phase |
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Stroke, Acute Stroke Hemiparesis |
Device: NMES device with EMG-triggered and Cyclic capabilities |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Electrical Stimulation for Upper Limb Recovery in Stroke |
Estimated Enrollment: | 189 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A. Cyclic stim: Active Comparator
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Device: NMES device with EMG-triggered and Cyclic capabilities
All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
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B. Sensory stim: Active Comparator
Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.
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Device: NMES device with EMG-triggered and Cyclic capabilities
All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
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C. EMG-Triggered: Active Comparator
EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be "rewarded" with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.
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Device: NMES device with EMG-triggered and Cyclic capabilities
All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
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Stroke is the leading cause of activity limitation among older adults in the United States. NeuroMuscular Electrical Stimulation (NMES) can be used by stroke survivors who do not have enough residual movement to take part in volitional active repetitive movement therapy and does not require expensive equipment or skilled personnel. Two types of NMES are available. The first is cyclic NMES, which electrically activates paretic muscles at a set duty cycle for a preset time period. (This study will employ both "traditional" cyclic stimulation and "sensory-only" stimulation, in which intensity is set at a level to be felt by the patient but insufficient to cause muscle contraction.)In cyclic NMES, the patient is a passive participant and does not assist the NMES by volitionally contracting the muscle during stimulation. The second type encompasses various forms of NMES in combination with biofeedback. For example, in "EMG-triggered" NMES, subjects are "rewarded" with stimulation in response to successful attempts to reach a pre-set level of EMG activity in the affected muscle. There is increased cognitive input and involvement on the part of the patient. The purpose of this study is to first demonstrate the effectiveness of these two types of surface stimulation on decreasing motor impairment and activity limitation; the study also seeks to assess the effect of adding cognitive input to NMES to reduce motor impairment and activity limitation.
Study subjects will be acute stroke survivors. They will participate for a total of eight months, beginning within the first six months after their stroke. Subjects will be randomly assigned to one of three treatment groups and will receive stimulation accordingly: 1) Cyclic stimulation; 2)Sensory-only stimulation; and 3)EMG-triggered stimulation. Members of each treatment group will be given an appropriate NMES device to use for two 40-minute treatment sessions per day, five times per week for eight weeks; for a total of 80 treatment sessions. Stimulation will be applied to ECR and EDC (wrist and finger extensors) on the affected arm. A treatment therapist will visit the patient at home on a weekly basis to monitor subject compliance and to provide feedback on device usage. The primary outcome measure will be the upper extremity portion of the Fugl-Meyer Motor Assessment (FMA), a measure of motor impairment. The modified Arm Motor Ability Test (mAMAT) is a hemiparetic arm-specific measure of activity limitation, and will serve as a secondary outcome measure.
In addition to the baseline visit on day of enrollment, subjects will complete these outcome measurements at the clinic on five other occasions: at mid-treatment (week 5); end of treatment (week 9); and for follow-up visits at one-, three- and six-months post-treatment.
Ages Eligible for Study: | 21 Years to 89 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cathy Corrigan, RN | 216-778-5347 | ccorrigan@metrohealth.org |
Contact: Peggy Maloney, RN | 216-778-5347 | mmaloney@metrohealth.org |
United States, Ohio | |
MetroHealth Medical Center | Recruiting |
Cleveland, Ohio, United States, 44109 | |
Contact: Cathy Corrigan, RN 216-778-5347 ccorrigan@metrohealth.org | |
Contact: Peggy Maloney, RN 216-778-5347 mmaloney@metrohealth.org | |
Principal Investigator: John Chae, MD | |
University of Cincinnati College of Medicine | Recruiting |
Cincinnati, Ohio, United States, 45267 | |
Contact: Stephen Page, PhD, FAHA 513-558-2754 stephen.page@uc.edu | |
Principal Investigator: Stephen Page, PhD, FAHA | |
Edwin Shaw Rehab - Akron General Medical Center | Recruiting |
Akron, Ohio, United States, 44312 | |
Contact: James Lee, PT 330-784-1271 ext 5179 jlee@edwinshaw.com | |
Principal Investigator: Michael Delahanty, DO |
Principal Investigator: | John Chae, MD | MetroHealth Medical Center |
Responsible Party: | MetroHealth Medical Center; Case Western Reserve University ( John Chae, MD ) |
Study ID Numbers: | R01HD049777, R01HD049777 |
Study First Received: | August 31, 2005 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00142792 |
Health Authority: | United States: Federal Government |
stroke recovery of function functional electrical stimulation (FES) |
Paresis Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases |
Cerebrovascular Disorders Signs and Symptoms Neurologic Manifestations Brain Ischemia Brain Infarction Infarction |
Nervous System Diseases Cardiovascular Diseases |