Strength Training Using Neuromuscular Electrical Stimulation For Children With Cerebral Palsy
NCT ID: NCT00356343
Last Updated: 2011-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
45 participants
INTERVENTIONAL
2004-07-31
Brief Summary
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Detailed Description
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Subjects is the NMES group will be implanted with percutaneous electrodes in the medial and lateral heads of the gastrocnemius and the quadriceps (3 electrodes in each lower extremity, implanted bilaterally). During the intervention phase, these subjects will undergo 15 electrically-elicited contractions in each of the implanted muscle groups three times/week (at home), while positioned on an exercise board to maintain good alignment and facilitate isometric contractions. Subjects in the volitional group will perform 15 isometric contractions in each muscle group (quadriceps, triceps surae), while positioned on an exercise board. The non-exercise control group will continue with typical activities, but no intervention will be administered. Subjects are assessed at baseline, 6 weeks into the intervention, 12 weeks into the intervention (at which point the intervention is withdrawn), and at a follow-up assessment 12 weeks after the withdrawal of the intervention.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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NMES Strengthening Group
Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles.
NMES Strength Training
Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles.
Control Group
No Intervention Control Group
No interventions assigned to this group
Volitional Strengthening
Subjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles.
Volitional Strength Training
Subjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles.
Interventions
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NMES Strength Training
Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles.
Volitional Strength Training
Subjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of spastic diplegic cerebral palsy
* GMFCS level of II or III (able to walk indoors and outdoors with or without an assistive device)
* PROM requirements (\<10 degree hip flexion contracture, \>20 degrees of hip abduction, \< 5 degrees of knee flexion contracture, \> 45 degree popliteal angle, ankle dorsiflexion to neutral with knee extension)
* Sufficient cognitive/communication skills to perform volitional muscle contractions and complete data collection procedures
Exclusion Criteria
* Must be at least one year post orthopedic surgery
* Must be at least 6 months post botulinum toxin injections
* Uncontrolled seizure activity
7 Years
12 Years
ALL
No
Sponsors
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Shriners Hospitals for Children
OTHER
University of Delaware
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Responsible Party
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University of DE/Shriners Hospitals for Children
Principal Investigators
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Samuel CK Lee, PhD, PT
Role: PRINCIPAL_INVESTIGATOR
University of Delaware, Shriners Hospitals for Children
Locations
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Shriners Hospitals for Children, Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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Stackhouse SK, Binder-Macleod SA, Lee SC. Voluntary muscle activation, contractile properties, and fatigability in children with and without cerebral palsy. Muscle Nerve. 2005 May;31(5):594-601. doi: 10.1002/mus.20302.
Other Identifiers
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