Strength Training Using Neuromuscular Electrical Stimulation For Children With Cerebral Palsy

Spastic Diplegic Cerebral Palsy Clinical Trial

Official title:

Strength Training Using NMES for Children With Cerebral Palsy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00356343
• Other study ID #: R01HD043859
• Status: Active, not recruiting
• Phase: Phase 1
• First received: July 25, 2006
• Last updated: January 9, 2011
• Start date: July 2004

Study information

• Verified date: January 2011
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Spastic Diplegic Cerebral Palsy

Intervention

Device:
• NMES Strength Training
Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in 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.

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children, Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Shriners Hospitals for Children, University of Delaware

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Force generating ability of quadriceps femoris and triceps surae (MVIC)		Pre, Mid, Post, Washout	No
Primary	Voluntary muscle activation during a Maximal Volitional Isometric Contraction (MVIC)		Pre, Mid, Post, Washout	No
Primary	Antagonist coactivation during an agonist MVIC		Pre, Mid, Post, Washout	No
Primary	Contractile properties as assessed via electrically-elicited tests		Pre, Mid, Post, Washout	No
Primary	Fatiguability of muscle as assessed via electrically-elicited tests		Pre, Mid, Post, Washout	No
Primary	Muscle cross-sectional area of quadriceps femoris and triceps surae (via MRI with fat suppression)		Pre, Mid, Post, Washout	No
Primary	Spatiotemporal parameters of gait		Pre, Mid, Post, Washout	No
Primary	Gross Motor Function Measure		Pre, Mid, Post, Washout	No
Primary	Timed Up and Go		Pre, Mid, Post, Washout	No
Primary	Parent and child report via questionnaires (PODCI, COPM)		Pre, Mid, Post, Washout	No

External Links

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