NCT00356343

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Last Updated

January 11, 2011

Status Verified

January 1, 2011

Enrollment Period

5.2 years

First QC Date

July 25, 2006

Last Update Submit

January 9, 2011

Conditions

Spastic Diplegic Cerebral Palsy

Keywords

NMESCerebral PalsySpastic DiplegiaElectrical StimulationChildren

Outcome Measures

Primary Outcomes (10)

  • Force generating ability of quadriceps femoris and triceps surae (MVIC)

    Pre, Mid, Post, Washout

  • Voluntary muscle activation during a Maximal Volitional Isometric Contraction (MVIC)

    Pre, Mid, Post, Washout

  • Antagonist coactivation during an agonist MVIC

    Pre, Mid, Post, Washout

  • Contractile properties as assessed via electrically-elicited tests

    Pre, Mid, Post, Washout

  • Fatiguability of muscle as assessed via electrically-elicited tests

    Pre, Mid, Post, Washout

  • Muscle cross-sectional area of quadriceps femoris and triceps surae (via MRI with fat suppression)

    Pre, Mid, Post, Washout

  • Spatiotemporal parameters of gait

    Pre, Mid, Post, Washout

  • Gross Motor Function Measure

    Pre, Mid, Post, Washout

  • Timed Up and Go

    Pre, Mid, Post, Washout

  • Parent and child report via questionnaires (PODCI, COPM)

    Pre, Mid, Post, Washout

Study Arms (3)

NMES Strengthening Group

EXPERIMENTAL

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

Device: NMES Strength Training

Control Group

NO INTERVENTION

No Intervention Control Group

Volitional Strengthening

ACTIVE COMPARATOR

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

Other: Volitional Strength Training

Interventions

NMES Strength TrainingDEVICE

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

NMES Strengthening Group
Volitional Strength TrainingOTHER

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

Volitional Strengthening

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospitals for Children, Philadelphia

Philadelphia, Pennsylvania, 19140, United States

Location

Related 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. doi: 10.1002/mus.20302.

    PMID: 15779003RESULT

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Samuel CK Lee, PhD, PT

    University of Delaware, Shriners Hospitals for Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

July 25, 2006

First Posted

July 26, 2006

Study Start

July 1, 2004

Primary Completion

September 1, 2009

Last Updated

January 11, 2011

Record last verified: 2011-01

Locations

US(1)