search
Back to results

Functional Electrical Stimulation for Hemiplegic Cerebral Palsy

Primary Purpose

Hemiplegic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FES neuroprosthesis to dorsiflexors on affected leg
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegic Cerebral Palsy focused on measuring hemiplegia, cerebral palsy, neuroprosthesis, children

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FES neuroprosthesis to dorsiflexors on affected side

Arm Description

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

Outcomes

Primary Outcome Measures

peak ankle dorsiflexion range during swing phase in gait

Secondary Outcome Measures

gait efficiency

Full Information

First Posted
March 20, 2013
Last Updated
January 27, 2015
Sponsor
Children's Hospital Medical Center, Cincinnati
search

1. Study Identification

Unique Protocol Identification Number
NCT01817179
Brief Title
Functional Electrical Stimulation for Hemiplegic Cerebral Palsy
Official Title
Effects of Functional Electrical Stimulation Neuroprosthesis in Children With Hemiplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy
Keywords
hemiplegia, cerebral palsy, neuroprosthesis, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FES neuroprosthesis to dorsiflexors on affected side
Arm Type
Experimental
Arm Description
Participants will use FES neuroprosthesis to dorsiflexors on affected leg for 3 months at home.
Intervention Type
Other
Intervention Name(s)
FES neuroprosthesis to dorsiflexors on affected leg
Other Intervention Name(s)
Bioness L300
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
gait efficiency
Time Frame
after 3 months of neuroprosthesis use
Other Pre-specified Outcome Measures:
Title
functional skills
Description
will included timed up and downs stairs,six minute walk test, and an obstacle course
Time Frame
at baseline and 3 months after neuroprosthesis use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy F Bailes, PT, MS
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Functional Electrical Stimulation for Hemiplegic Cerebral Palsy

We'll reach out to this number within 24 hrs