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

This study has been completed.
Sponsor:
Collaborator:
Cerebral Palsy International Research Foundation
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01657994
First received: May 17, 2012
Last updated: August 31, 2016
Last verified: August 2016
History of Changes
  Purpose
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 Intervention
Cerebral Palsy
 Other: Combined functional electrical stimulation and robotic gait training

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in strength via myometry [ Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment ] [ Designated as safety issue: No ]
  • Change in Observational Gait Scale [ Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment ] [ Designated as safety issue: No ]
  • Change in Modified Ashworth Scale [ Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment ] [ Designated as safety issue: No ]
  • Change in Goniometry at the knee [ Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment ] [ Designated as safety issue: No ]
  • Change in 6 minute walk [ Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment ] [ Designated as safety issue: No ]
  • Change in 10 meter walk [ Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in Cerebral Palsy Quality of Life Questionnaire [ Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment ] [ Designated as safety issue: No ]
  • Change in Canadian Occupational Performance Measure [ Time Frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment ] [ Designated as safety issue: No ]
Enrollment: 6
Study Start Date: May 2012
Study Completion Date: September 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   5 Years to 12 Years   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01657994     History of Changes
Other Study ID Numbers: R-796-10 
Study First Received: May 17, 2012
Last Updated: August 31, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 27, 2016