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Strength Training Using Neuromuscular Electrical Stimulation For Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT00356343
Recruitment Status : Unknown
Verified January 2011 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Active, not recruiting
First Posted : July 26, 2006
Last Update Posted : January 11, 2011
Sponsor:
Collaborators:
Shriners Hospitals for Children
University of Delaware
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Condition or disease Intervention/treatment Phase
Spastic Diplegic Cerebral Palsy Device: NMES Strength Training Other: Volitional Strength Training Phase 1

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  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Strength Training Using NMES for Children With Cerebral Palsy
Study Start Date : July 2004
Estimated Primary Completion Date : September 2009


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.



Primary Outcome Measures :
  1. Force generating ability of quadriceps femoris and triceps surae (MVIC) [ Time Frame: Pre, Mid, Post, Washout ]
  2. Voluntary muscle activation during a Maximal Volitional Isometric Contraction (MVIC) [ Time Frame: Pre, Mid, Post, Washout ]
  3. Antagonist coactivation during an agonist MVIC [ Time Frame: Pre, Mid, Post, Washout ]
  4. Contractile properties as assessed via electrically-elicited tests [ Time Frame: Pre, Mid, Post, Washout ]
  5. Fatiguability of muscle as assessed via electrically-elicited tests [ Time Frame: Pre, Mid, Post, Washout ]
  6. Muscle cross-sectional area of quadriceps femoris and triceps surae (via MRI with fat suppression) [ Time Frame: Pre, Mid, Post, Washout ]
  7. Spatiotemporal parameters of gait [ Time Frame: Pre, Mid, Post, Washout ]
  8. Gross Motor Function Measure [ Time Frame: Pre, Mid, Post, Washout ]
  9. Timed Up and Go [ Time Frame: Pre, Mid, Post, Washout ]
  10. Parent and child report via questionnaires (PODCI, COPM) [ Time Frame: Pre, Mid, Post, Washout ]


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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( U.S. NIH Grant/Contract )
First Posted: July 26, 2006    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011

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:
Paralysis
Cerebral Palsy
Muscle Spasticity
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations