Functional Electrical Stimulation for Hemiplegic Cerebral Palsy

Not Applicable

Completed

• Conditions: Hemiplegic Cerebral Palsy
• Interventions: Other: FES neuroprosthesis to dorsiflexors on affected leg

• Registration Number: NCT01817179
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-03
• Study Start: 2013-03
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-22
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2015-01-27
• Last Update Posted: 2015-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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:

• Any metal implants containing electrical circuitry

• Continuous regular use of neuroprosthesis stimulation previous to study enrollment

• Previous orthopaedic procedure involving tibialis anterior muscle at any time

• Previous orthopaedic procedure to affected limb in the last year

• Botulinum toxin administered within the past 3 months, or plans for such treatment during the course of the study

• Any condition that PI feels would limit ambulatory progress (e.g. arthritis, uncontrolled seizures)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FES neuroprosthesis to dorsiflexors on affected side	FES neuroprosthesis to dorsiflexors on affected leg	Participants will use FES neuroprosthesis to dorsiflexors on affected leg for 3 months at home.

Primary Outcome Measures

Name	Time	Method
peak ankle dorsiflexion range during swing phase in gait	will be assessed at baseline and 3 months after continous use of neuroprosthesis

Secondary Outcome Measures

Name	Time	Method
gait efficiency	after 3 months of neuroprosthesis use

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States