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Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy
This study has been completed.
Sponsor:
Children's Hospital Medical Center, Cincinnati
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
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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: | 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:
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 ]
Secondary Outcome Measures:
- Change in strength via myometry [ Time Frame: 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 ]
- Change in Modified Ashworth Scale [ Time Frame: 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 ]
- Change in 6 minute walk [ Time Frame: 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 ]
- 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 ]
- Change in Cerebral Palsy Quality of Life Questionnaire [ Time Frame: 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 ]
| 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:
|
Eligibility| 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
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
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 |
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 June 23, 2017