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NCT01086670 · ClinicalTrials.gov registry record · Phase 1
Physical, Functional and Neural Effects of Two Lower Extremity Exercise Protocols in Children With Cerebral Palsy
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT01086670: Completed Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT01086670 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01086670, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
Background: * Many people who have cerebral palsy (CP) have spastic diplegia, which affects the legs and causes difficulty with leg movement and walking. Research has shown that exercise can help those with CP learn to move their arms better, but more research is needed to determine whether exercise programs can improve leg movements in people with CP. * Walking on a treadmill with the help of a physical therapist has improved the treatment outcomes of some individuals with spinal cord injuries. Many children with CP already have physical therapy but still have trouble with walking and leg coordination. Two other kinds of exercise machines, a stationary bicycle and an elliptical machine, used in the home, may be able to help children with CP walk better and move their legs better. Objectives: * To see how children with cerebral palsy (CP) move their legs differently from children without CP. * To see if an exercise program can improve leg coordination in children with CP. Eligibility: \- Children between 5 and 17 years of age who either have spastic diplegia CP or are healthy volunteers. Design: * Children who are able and willing will have magnetic resonance imaging (MRI) scans at the start and the end of the study. * During Part I of the study, participants will demonstrate their leg and muscle function with the following tests: * Measurement of leg size and movement * Combined camera motion study and electrical impulse evaluation to assess how well the participant walks (with or without an assistive device, as needed) * Leg movement tests on an exercise bicycle and elliptical machine * Tests of leg muscle strength, stiffness, and effectiveness * Ultrasound scans of leg muscle * Parents of participants will complete computer-based questionnaires about their child s motor abilities. * A smaller group of participants will continue to Part II of the study, which involves regular exercise of 20 minutes a day, 5 days a week, for 3 months, on a stationary bicycle
Primary Outcome
Cadence is the number of device cycles or gait cycles performed in a minute.
Interventions
- OTHER Physical Exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2010-03-30 |
| Est. Completion | 2016-05-09 |
| Phase | Phase 1 |
What the finished NCT01086670 record still lists
NCT01086670 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Physical Exercise is the first listed.
NCT01086670 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01086670 about?
NCT01086670 is a clinical study titled "Physical, Functional and Neural Effects of Two Lower Extremity Exercise Protocols in Children With Cerebral Palsy". Background: * Many people who have cerebral palsy (CP) have spastic diplegia, which affects the legs and causes difficulty with leg movement and walking. Research has shown that exercise can help those with CP learn to move their arms better, but more research is needed to determine whether exercis...
What is the current status of trial NCT01086670?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2010-03-30. Estimated completion is 2016-05-09.
What interventions are being tested in trial NCT01086670?
The interventions under investigation include: Physical Exercise (OTHER).
Who is sponsoring clinical trial NCT01086670?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01086670's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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