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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: Combined functional electrical stimulation and robotic gait training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 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: therapy plus fes<br>robotic gait training plus functional electrical stimulation | Other: Combined functional electrical stimulation and robotic gait training<br>* up to 18 sessions of approximately 45 minutes occurring over up to 9 weeks<br>* Other names: RT-50;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gross Motor Function Measure-66 using multiple baseline assessments |  | 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy, gait training, robotic, functional electrical stimulation