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

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ClinicalTrials.gov Identifier: NCT01657994
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : September 1, 2016
Sponsor:
Collaborator:
Cerebral Palsy International Research Foundation
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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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

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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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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657994


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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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    Key Record Dates
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