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Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combined functional electrical stimulation and robotic gait training
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 Cerebral Palsy focused on measuring cerebral palsy, gait training, robotic, functional electrical stimulation

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • GMFCS II, III, or IV cerebral palsy
  • 5-12 years of age
  • meet safety criteria for robotic gait training (<300 lbs, intact skin, femoral length 21-47 cm, ability to follow simple instructions)
  • meet safety criteria for functional electrical stimulation (voluntary hip and knee muscle contraction, intact skin)

Exclusion Criteria:

  • planned major intervention during study period
  • contractures that interfere with upright stance
  • history of non-traumatic long bone fracture or clinically significant osteoporosis
  • significant concurrent illness
  • significant condition not typically associated with cerebral palsy

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

therapy plus fes

Arm Description

robotic gait training plus functional electrical stimulation

Outcomes

Primary Outcome Measures

Change in Gross Motor Function Measure-66 using multiple baseline assessments

Secondary Outcome Measures

Change in strength via myometry
Change in Observational Gait Scale
Change in Modified Ashworth Scale
Change in Goniometry at the knee
Change in 6 minute walk
Change in 10 meter walk
Change in Children's Assessment of Participation and Enjoyment
Change in Cerebral Palsy Quality of Life Questionnaire
Change in Canadian Occupational Performance Measure

Full Information

First Posted
May 17, 2012
Last Updated
August 31, 2016
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Cerebral Palsy International Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01657994
Brief Title
Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy
Official Title
Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Cerebral Palsy International Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to learn more about the usefulness of a physical therapy treatment that combines robot-assisted walking with electrical impulses that help to make muscles contract. This treatment is intended for children with cerebral palsy. Up to eleven children with cerebral palsy will receive up to 18 treatments and will have several evaluations before and after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, gait training, robotic, functional electrical stimulation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
therapy plus fes
Arm Type
Experimental
Arm Description
robotic gait training plus functional electrical stimulation
Intervention Type
Other
Intervention Name(s)
Combined functional electrical stimulation and robotic gait training
Other Intervention Name(s)
Lokomat, RT-50
Intervention Description
up to 18 sessions of approximately 45 minutes occurring over up to 9 weeks
Primary Outcome Measure Information:
Title
Change in Gross Motor Function Measure-66 using multiple baseline assessments
Time Frame
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Secondary Outcome Measure Information:
Title
Change in strength via myometry
Time Frame
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Title
Change in Observational Gait Scale
Time Frame
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Title
Change in Modified Ashworth Scale
Time Frame
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Title
Change in Goniometry at the knee
Time Frame
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Title
Change in 6 minute walk
Time Frame
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Title
Change in 10 meter walk
Time Frame
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Title
Change in Children's Assessment of Participation and Enjoyment
Time Frame
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Title
Change in Cerebral Palsy Quality of Life Questionnaire
Time Frame
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Title
Change in Canadian Occupational Performance Measure
Time Frame
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: GMFCS II, III, or IV cerebral palsy 5-12 years of age meet safety criteria for robotic gait training (<300 lbs, intact skin, femoral length 21-47 cm, ability to follow simple instructions) meet safety criteria for functional electrical stimulation (voluntary hip and knee muscle contraction, intact skin) Exclusion Criteria: planned major intervention during study period contractures that interfere with upright stance history of non-traumatic long bone fracture or clinically significant osteoporosis significant concurrent illness significant condition not typically associated with cerebral palsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jilda Vargus-Adams, MD MSc
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

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Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy

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