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| ID | Type | Description | Link |
|---|---|---|---|
| 10-CC-0073 |
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Background:
Objectives:
Eligibility:
- Children between 5 and 17 years of age who either have spastic diplegia CP or are healthy volunteers.
Design:
Objectives:
Our primary objectives are to: 1) characterize and compare lower extremity motor coordination in children with cerebral palsy (CP) across mobility levels and to children without CP; and 2) evaluate the effects of two home-based exercise programs on motor coordination, as well as other physical, functional and neurological outcomes in children with CP. We hypothesize children with CP will exhibit significant coordination deficits compared to those without CP and that each exercise program will lead to significant improvements in outcomes.
Study Population:
Objective 1 will include 60 ambulatory children with spastic diplegic CP (20 in each of three mobility levels) and 20 children without CP within the same age range. Forty (40) children with CP will participate in Objective 2; 20 in each exercise group.
Design:
In Objective 1, the multiple measures taken at a single point in time will be compared across the three CP and the control groups. Children with CP from Objective 1 will be invited consecutively to participate in the exercise program (Objective 2), until enrollment is complete. Participation in Objective 2 lasts for 6 months. Subjects will be randomly assigned to use one of two novel lower extremity exercise devices: a motor-assisted cycle or an elliptical trainer. Children will exercise for 20 minutes, 5 days a week for 12 consecutive weeks. The major goal of each is to increase the ability to cycle or step at a rapid pace (the target goal is 40 RPM), with resistance added once speed goals are attained and thereafter progressed gradually. The timing of the exercise period (immediate vs. delayed for 3 months) will also be randomly assigned allowing assessors to be masked to group assignment.
Outcome Measures:
The primary outcome is the difference (Objective 1) or pre to post-exercise change (Objective 2) in coordination as measured by the fastest active (voluntary) cadence with each device. Additional coordination measures include cadence at free speed, variability in cadence, and EMG reciprocation vs. synchronization. Selective Control Assessment for the Lower extremity (SCALE), strength and spasticity tests and ultrasound measures of muscle size will be assessed at each time point. These will be compared across groups and before and after the two exercise programs. Functional outcomes include gait speed and two validated computer-based questionnaires. Neural outcomes include selected measures of gray and white matter connectivity as assessed with fcMRI and DTI, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Subjects will be randomly assigned to use one of two novel lower extremity exercise devices: a motor-assisted cycle or an elliptical trainer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Exercise | Other | Children will be assigned either an elliptical machine or cycle to take home. Each exercise will be performed for 20 minutes per day, 5 days per week for a period of 12 consecutive weeks, or 60 sessions in all. To avoid excessive fatigue or over-training effects, children are asked to adhere to this exact schedule and not to exercise more than this. Children are asked to complete as many of the sessions as they can. To allow for sick days or vacation during the program, the duration of the training can be extended up to 2 more weeks if needed to try to complete all 60 sessions. Compliance (percent sessions completed) will be correlated with outcomes in the statistical analyses. |
| Measure | Description | Time Frame |
|---|---|---|
| Coordination as measured by fast cadence during device and walking | Cadence is the number of device cycles or gait cycles performed in a minute. | per test, 3 months post test, 3 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 3D Motion Capture of walking, cycling and elliptical, Surface electromyography, Selective Control Assessment of Lower Extremities, Physical examination, Muscle Ultrasound. strength and spasticity, Questionnaires, Magnetic Resonance Imaging | Tests will be presented in the same order at each assessment, with the 3D motion assessments of the cycling and steppingperformed first since these involve collection of the primary outcome measure, cadence. |
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A. For those without CP (healthy volunteers)
B. For those with CP
EXCLUSION CRITERIA:
A. For those without CP (healthy volunteers)
1. Have a history of musculoskeletal or neurological injury or disorder or general medical condition that would affect the use of the legs or limit the ability to safely perform motor testing
B. For those with CP:
ADDITIONAL EXCLUSION CRITERIA FOR THOSE HAVING A MRI:
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| Name | Affiliation | Role |
|---|---|---|
| Diane L Damiano, Ph.D. | National Institutes of Health Clinical Center (CC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
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| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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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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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 12 weeks |