Cerebral Palsy
Conditions
Keywords
cerebral palsy, gait training, robotic, functional electrical stimulation
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.
Interventions
OTHERCombined functional electrical stimulation and robotic gait training
up to 18 sessions of approximately 45 minutes occurring over up to 9 weeks
Sponsors
Cerebral Palsy International Research Foundation
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Observational Gait Scale | 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment |
| 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 strength via myometry | 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 |
| Change in 10 meter walk | 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment |
Countries
United States
Outcome results
None listed