Functional Electrical Stimulation for Hemiplegic Cerebral Palsy

Study Overview
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Brief Summary
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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.

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

Conditions
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Hemiplegic Cerebral Palsy

Intervention / Treatment
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* Other: FES neuroprosthesis to dorsiflexors on affected leg


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FES neuroprosthesis to dorsiflexors on affected side<br>Participants will use FES neuroprosthesis to dorsiflexors on affected leg for 3 months at home. | Other: FES neuroprosthesis to dorsiflexors on affected leg<br> <br> * Other names: Bioness L300;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gait efficiency |  | after 3 months of neuroprosthesis use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemiplegia, cerebral palsy, neuroprosthesis, children