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Strength Training Using Neuromuscular Electrical Stimulation For Children With Cerebral Palsy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Shriners Hospitals for Children
University of Delaware
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00356343
First received: July 25, 2006
Last updated: January 9, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Spastic Diplegic Cerebral Palsy
 Device: NMES Strength Training
Other: Volitional Strength Training
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Strength Training Using NMES for Children With Cerebral Palsy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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

Estimated Enrollment: 45
Study Start Date: July 2004
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356343

Locations
United States, Pennsylvania
Shriners Hospitals for Children, Philadelphia
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Shriners Hospitals for Children
University of Delaware
Investigators
Principal Investigator: Samuel CK Lee, PhD, PT University of Delaware, Shriners Hospitals for Children
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Samuel C.K. Lee, University of DE/Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00356343     History of Changes
Other Study ID Numbers: R01HD043859
Study First Received: July 25, 2006
Last Updated: January 9, 2011
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
NMES
Cerebral Palsy
Spastic Diplegia
Electrical Stimulation
Children

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013