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

August 31, 2016 updated by: Children's Hospital Medical Center, Cincinnati
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: therapy plus fes
robotic gait training plus functional electrical stimulation
Other: Combined functional electrical stimulation and robotic gait training
up to 18 sessions of approximately 45 minutes occurring over up to 9 weeks
Other Names:
  • Lokomat
  • RT-50

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in strength via myometry
Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Observational Gait Scale
Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Modified Ashworth Scale
Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Goniometry at the knee
Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in 6 minute walk
Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in 10 meter walk
Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
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
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Cerebral Palsy Quality of Life Questionnaire
Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Canadian Occupational Performance Measure
Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Cerebral Palsy International Research Foundation

Investigators

  • Principal Investigator: Jilda Vargus-Adams, MD MSc, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

May 17, 2012

First Submitted That Met QC Criteria

August 1, 2012

First Posted (ESTIMATE)

August 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-796-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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