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Strength Training Using Neuromuscular Electrical Stimulation For Children With Cerebral Palsy
This study is currently recruiting participants.
Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), July 2006
Sponsors and Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
  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
Cerebral Palsy (Spastic Diplegia)
Procedure: electrical stimulation training
Procedure: voluntary exercise
Procedure: non-intervention control group
Phase I

MedlinePlus related topics: Cerebral Palsy Exercise and Physical Fitness Paralysis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title: Strength Training Using NMES for Children With Cerebral Palsy

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)
  • 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)

Estimated Enrollment: 45
Study Start Date: July 2004
Estimated Study Completion Date: June 2009
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

Contacts
Contact: Samuel CK Lee, PhD, PT 215-430-4083 sclee@shrinenet.org
Contact: Ann M Tokay, DPT 215-430-4223 atokay@shrinenet.org

Locations
United States, Pennsylvania
Shriners Hospitals for Children, Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Samuel CK Lee, PhD, PT     215-430-4083     sclee@shrinenet.org    
Sub-Investigator: Stuart A Binder-Macleod, PhD            
Sub-Investigator: James J McCarthy, MD            
Sub-Investigator: Ann M Tokay, DPT            
Sub-Investigator: Laura A Prosser, MPT            
Sponsors and Collaborators
Shriners Hospitals for Children
University of Delaware
Investigators
Principal Investigator: Samuel CK Lee, PhD, PT University of Delaware, Shriners Hospitals for Children
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: R01HD043859
Study First Received: July 25, 2006
Last Updated: July 26, 2006
ClinicalTrials.gov Identifier: NCT00356343  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Paralysis
Cerebral Palsy
Brain Damage, Chronic
Central Nervous System Diseases
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009