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Clinical Trials/NCT01817179
NCT01817179
Completed
N/A

Effects of Functional Electrical Stimulation Neuroprosthesis in Children With Hemiplegic Cerebral Palsy

Children's Hospital Medical Center, Cincinnati1 site in 1 country12 target enrollmentMarch 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hemiplegic Cerebral Palsy
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
12
Locations
1
Primary Endpoint
peak ankle dorsiflexion range during swing phase in gait
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this study is to evaluate how a functional electrical stimulation (FES) device worn on the lower leg effects how children (ages 6-17 years) with hemiplegic cerebral palsy walk and perform other functional activities.

The investigators expect to find that wearing the functional electrical stimulation device will improve walking and other functional activities of children with hemiplegic cerebral palsy. Participants will be trained in use of the device and will be required to wear it daily for 3 months. Each participant will be evaluated before beginning the intervention and after completing the intervention. This study will provide important information regarding the benefits of this treatment intervention in children with hemiplegic cerebral palsy.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
December 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of hemiplegic Cerebral Palsy
  • Gross Motor Function Classification System (GMFCS) I or II
  • Age 6-17 years inclusive
  • Demonstrate foot drop during gait without wearing ankle foot orthosis
  • Tolerance to neuroprosthesis stimulation
  • Physician referral to participate in intervention
  • Passive dorsiflexion to at least neutral with knee extended
  • Available to travel to and from study visits
  • Ability to follow instructions and cooperate with study protocol
  • Caregiver reads and understands English

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

peak ankle dorsiflexion range during swing phase in gait

Time Frame: will be assessed at baseline and 3 months after continous use of neuroprosthesis

Secondary Outcomes

  • gait efficiency(after 3 months of neuroprosthesis use)

Study Sites (1)

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