Overview

This trial is active, not recruiting.

Condition spastic diplegic cerebral palsy
Treatments nmes strength training, volitional strength training
Phase phase 1
Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator Shriners Hospitals for Children
Start date July 2004
End date September 2009
Trial size 45 participants
Trial identifier NCT00356343, R01HD043859

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
(No Intervention)
No Intervention Control Group
(Active Comparator)
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.

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 7 years up to 12 years old.

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

Additional Information

Official title Strength Training Using NMES for Children With Cerebral Palsy
Principal investigator Samuel CK Lee, PhD, PT
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).