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| Name | Class |
|---|---|
| Cerebral Palsy International Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| therapy plus fes | Experimental | robotic gait training plus functional electrical stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined functional electrical stimulation and robotic gait training | Other | up to 18 sessions of approximately 45 minutes occurring over up to 9 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gross Motor Function Measure-66 using multiple baseline assessments | 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in strength via myometry | 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment | |
| Change in Observational Gait Scale | 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jilda Vargus-Adams, MD MSc | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Change in Modified Ashworth Scale | 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment |
| Change in Goniometry at the knee | 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment |
| Change in 6 minute walk | 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment |
| Change in 10 meter walk | 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment |
| Change in Children's Assessment of Participation and Enjoyment | 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment |
| Change in Cerebral Palsy Quality of Life Questionnaire | 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment |
| Change in Canadian Occupational Performance Measure | 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment |