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

Arm | Intervention/treatment |
---|---|
Experimental: therapy plus fes
robotic gait training plus functional electrical stimulation
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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:
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- 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 ]
- 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 ]

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

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
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229 |
Principal Investigator: | Jilda Vargus-Adams, MD MSc | Children's Hospital Medical Center, Cincinnati |
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 |