Clinical trial NCT00356343: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Spastic Diplegic Cerebral Palsy
Keywords: NMES
Cerebral Palsy
Spastic Diplegia
Electrical Stimulation
Children
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
Collaborators: name: Shriners Hospitals for Children
name: University of Delaware
First posted: 2006-07-26
Enrollment: 45
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Force generating ability of quadriceps femoris and triceps surae (MVIC)
timeFrame: Pre, Mid, Post, Washout
measure: Voluntary muscle activation during a Maximal Volitional Isometric Contraction (MVIC)
timeFrame: Pre, Mid, Post, Washout
measure: Antagonist coactivation during an agonist MVIC
timeFrame: Pre, Mid, Post, Washout
measure: Contractile properties as assessed via electrically-elicited tests
timeFrame: Pre, Mid, Post, Washout
measure: Fatiguability of muscle as assessed via electrically-elicited tests
timeFrame: Pre, Mid, Post, Washout
measure: Muscle cross-sectional area of quadriceps femoris and triceps surae (via MRI with fat suppression)
timeFrame: Pre, Mid, Post, Washout
measure: Spatiotemporal parameters of gait
timeFrame: Pre, Mid, Post, Washout
measure: Gross Motor Function Measure
timeFrame: Pre, Mid, Post, Washout
measure: Timed Up and Go
timeFrame: Pre, Mid, Post, Washout
measure: Parent and child report via questionnaires (PODCI, COPM)
timeFrame: Pre, Mid, Post, Washout
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Shriners Hospitals for Children, Philadelphia
state: Pennsylvania
Study officials:
affiliation: University of Delaware, Shriners Hospitals for Children
name: Samuel CK Lee, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
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.