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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Cerebral Palsy	Other: Combined functional electrical stimulation and robotic gait training	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	6 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy
Study Start Date :	May 2012
Actual Primary Completion Date :	July 2013
Actual Study Completion Date :	September 2013

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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 Measures :

1. Change in strength via myometry [ Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment ]
2. Change in Observational Gait Scale [ Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment ]
3. Change in Modified Ashworth Scale [ Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment ]
4. Change in Goniometry at the knee [ Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment ]
5. Change in 6 minute walk [ Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment ]
6. Change in 10 meter walk [ Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment ]
7. 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 ]
8. Change in Cerebral Palsy Quality of Life Questionnaire [ Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment ]
9. Change in Canadian Occupational Performance Measure [ Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	5 Years to 12 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Cerebral Palsy International Research Foundation

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:	NCT01657994 History of Changes
Other Study ID Numbers:	R-796-10
First Posted:	August 6, 2012
Last Update Posted:	September 1, 2016
Last Verified:	August 2016

Keywords provided by Children's Hospital Medical Center, Cincinnati:

cerebral palsy; gait training; robotic; functional electrical stimulation

Additional relevant MeSH terms:

Paralysis; Cerebral Palsy; Neurologic Manifestations; Nervous System Diseases	Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases