Functional Electrical Stimulation for Hemiplegic Cerebral Palsy

NCT ID: NCT01817179

Last Updated: 2015-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-12-31

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.

Detailed Description

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Conditions

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Hemiplegic Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FES neuroprosthesis to dorsiflexors on affected side

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

Group Type EXPERIMENTAL

FES neuroprosthesis to dorsiflexors on affected leg

Intervention Type OTHER

Interventions

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FES neuroprosthesis to dorsiflexors on affected leg

Intervention Type OTHER

Other Intervention Names

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Bioness L300

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)
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy F Bailes, PT, MS

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CIN001-Effects of FES/PwP

Identifier Type: -

Identifier Source: org_study_id

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