Strength Training Using Neuromuscular Electrical Stimulation For Children With Cerebral Palsy

Strength Training Using NMES for Children With Cerebral Palsy

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.

Study Overview

• Status: Unknown
• Conditions: Spastic Diplegic Cerebral Palsy
• Intervention / Treatment: Device: NMES Strength Training; Other: Volitional Strength Training

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at baseline, 6 weeks into the intervention, 12 weeks into the intervention (at which point the intervention is withdrawn), and at a follow-up assessment 12 weeks after the withdrawal of the intervention.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Shriners Hospitals for Children, Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NMES Strengthening Group; Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles.	Device: 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: Control Group; No Intervention Control Group
Active Comparator: Volitional Strengthening; 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 volitional isometric strength training of bilateral quadriceps and triceps surae muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Collaborators: Shriners Hospitals for Children; University of Delaware
• Investigators: Principal Investigator: Samuel CK Lee, PhD, PT, University of Delaware, Shriners Hospitals for Children

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Anticipated): September 1, 2009

Study Registration Dates

• First Submitted: July 25, 2006
• First Submitted That Met QC Criteria: July 25, 2006
• First Posted (Estimate): July 26, 2006

Study Record Updates

• Last Update Posted (Estimate): January 11, 2011
• Last Update Submitted That Met QC Criteria: January 9, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Children; Electrical Stimulation; Spastic Diplegia; NMES
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Paralysis; Muscle Spasticity
• Other Study ID Numbers: R01HD043859 (U.S. NIH Grant/Contract)