A Phase 1 interventional study of NMES Strength Training and Volitional Strength Training in Spastic Diplegic Cerebral Palsy, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Status unknown at 1 site in United States. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2011-01-11.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Phase 1, Interventional, and Treatment
The purpose of this study is to determine if using high-intensity, short-duration, intermittent neuromuscular electrical stimulation (NMES) is better than volitional exercise in increasing quadriceps femoris and triceps surae force-generating potential and gross motor function in children with cerebral palsy.
The overall goal of this study is to determine if using high-intensity, short-duration, intermittent neuromuscular electrical stimulation (NMES) is better than volitional exercise in increasing quadriceps femoris and triceps surae force-generating potential and gross motor function in children with cerebral palsy. This study consists of a randomized controlled trial in which the effects of NMES applied to the quadriceps femoris and triceps surae are compared to the effects of volitional isometric exercise and a non-exercising control group. This project assesses the ability of NMES to increase muscle force generating ability, the mechanisms behind changes in force generating ability, and the effects of training on spatiotemporal parameters of gait and gross motor function in children with cerebral palsy.
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.
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This study's planned enrollment of 45 is above the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
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Exclusion Criteria:
Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles.
Device: NMES Strength Training
No Intervention Control Group
Subjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles.
Other: Volitional Strength Training
Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles.
Subjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles.
Force generating ability of quadriceps femoris and triceps surae (MVIC)
Time frame: Pre, Mid, Post, Washout
Voluntary muscle activation during a Maximal Volitional Isometric Contraction (MVIC)
Time frame: Pre, Mid, Post, Washout
Antagonist coactivation during an agonist MVIC
Time frame: Pre, Mid, Post, Washout
Contractile properties as assessed via electrically-elicited tests
Time frame: Pre, Mid, Post, Washout
Fatiguability of muscle as assessed via electrically-elicited tests
Time frame: Pre, Mid, Post, Washout
Muscle cross-sectional area of quadriceps femoris and triceps surae (via MRI with fat suppression)
Time frame: Pre, Mid, Post, Washout
Spatiotemporal parameters of gait
Time frame: Pre, Mid, Post, Washout
Gross Motor Function Measure
Time frame: Pre, Mid, Post, Washout
Timed Up and Go
Time frame: Pre, Mid, Post, Washout
Parent and child report via questionnaires (PODCI, COPM)
Time frame: Pre, Mid, Post, Washout
This study is status unknown, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)