Strength Training Using Neuromuscular Electrical Stimulation For Children With Cerebral Palsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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assessed at baseline, 6 weeks into the intervention, 12 weeks into the intervention (at which point the intervention is withdrawn), and at a follow-up assessment 12 weeks after the withdrawal of the intervention.

Official Title
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Strength Training Using NMES for Children With Cerebral Palsy

Conditions
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Spastic Diplegic Cerebral Palsy

Intervention / Treatment
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* Device: NMES Strength Training
* Other: Volitional Strength Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children ages 7-12 years old 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: Significant orthopedic impairments (hip MIGR > 40%, significant scoliosis) Must be at least one year post orthopedic surgery Must be at least 6 months post botulinum toxin injections Uncontrolled seizure activity

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NMES Strengthening Group<br>Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles. | Device: NMES Strength Training<br>* Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles.<br>|
| No Intervention: Control Group<br>No Intervention Control Group | |
| Active Comparator: Volitional Strengthening<br>Subjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles. | Other: Volitional Strength Training<br>* Subjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Force generating ability of quadriceps femoris and triceps surae (MVIC) |  | Pre, Mid, Post, Washout | 
| Voluntary muscle activation during a Maximal Volitional Isometric Contraction (MVIC) |  | Pre, Mid, Post, Washout | 
| Antagonist coactivation during an agonist MVIC |  | Pre, Mid, Post, Washout | 
| Contractile properties as assessed via electrically-elicited tests |  | Pre, Mid, Post, Washout | 
| Fatiguability of muscle as assessed via electrically-elicited tests |  | Pre, Mid, Post, Washout | 
| Muscle cross-sectional area of quadriceps femoris and triceps surae (via MRI with fat suppression) |  | Pre, Mid, Post, Washout | 
| Spatiotemporal parameters of gait |  | Pre, Mid, Post, Washout | 
| Gross Motor Function Measure |  | Pre, Mid, Post, Washout | 
| Timed Up and Go |  | Pre, Mid, Post, Washout | 
| Parent and child report via questionnaires (PODCI, COPM) |  | Pre, Mid, Post, Washout | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NMES, Cerebral Palsy, Spastic Diplegia, Electrical Stimulation, Children