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Strength Training Using Neuromuscular Electrical Stimulation For Children With Cerebral Palsy

Primary Purpose

Spastic Diplegic Cerebral Palsy

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NMES Strength Training
Volitional Strength Training
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Diplegic Cerebral Palsy focused on measuring NMES, Cerebral Palsy, Spastic Diplegia, Electrical Stimulation, Children

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shriners Hospitals for Children, Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Active Comparator

Arm Label

NMES Strengthening Group

Control Group

Volitional Strengthening

Arm Description

Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles.

No Intervention Control Group

Subjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 25, 2006
Last Updated
January 9, 2011
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Shriners Hospitals for Children, University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT00356343
Brief Title
Strength Training Using Neuromuscular Electrical Stimulation For Children With Cerebral Palsy
Official Title
Strength Training Using NMES for Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2004 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Diplegic Cerebral Palsy
Keywords
NMES, Cerebral Palsy, Spastic Diplegia, Electrical Stimulation, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NMES Strengthening Group
Arm Type
Experimental
Arm Description
Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No Intervention Control Group
Arm Title
Volitional Strengthening
Arm Type
Active Comparator
Arm Description
Subjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles.
Intervention Type
Device
Intervention Name(s)
NMES Strength Training
Intervention Description
Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles.
Intervention Type
Other
Intervention Name(s)
Volitional Strength Training
Intervention Description
Subjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles.
Primary Outcome Measure Information:
Title
Force generating ability of quadriceps femoris and triceps surae (MVIC)
Time Frame
Pre, Mid, Post, Washout
Title
Voluntary muscle activation during a Maximal Volitional Isometric Contraction (MVIC)
Time Frame
Pre, Mid, Post, Washout
Title
Antagonist coactivation during an agonist MVIC
Time Frame
Pre, Mid, Post, Washout
Title
Contractile properties as assessed via electrically-elicited tests
Time Frame
Pre, Mid, Post, Washout
Title
Fatiguability of muscle as assessed via electrically-elicited tests
Time Frame
Pre, Mid, Post, Washout
Title
Muscle cross-sectional area of quadriceps femoris and triceps surae (via MRI with fat suppression)
Time Frame
Pre, Mid, Post, Washout
Title
Spatiotemporal parameters of gait
Time Frame
Pre, Mid, Post, Washout
Title
Gross Motor Function Measure
Time Frame
Pre, Mid, Post, Washout
Title
Timed Up and Go
Time Frame
Pre, Mid, Post, Washout
Title
Parent and child report via questionnaires (PODCI, COPM)
Time Frame
Pre, Mid, Post, Washout

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel CK Lee, PhD, PT
Organizational Affiliation
University of Delaware, Shriners Hospitals for Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospitals for Children, Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15779003
Citation
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.
Results Reference
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Strength Training Using Neuromuscular Electrical Stimulation For Children With Cerebral Palsy

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