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NCT01253083 · ClinicalTrials.gov registry record · Phase 1
Mobility Training to Improve Motor Behavior in Toddlers With or at Risk for Cerebral Palsy: A Pilot Study
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01253083 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 5 participants.
The verdict
NCT01253083, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: \- People who have cerebral palsy often have difficulty walking and moving their legs. Cerebral palsy is sometimes not identified until a child is almost 2 years of age, which means that early motor skill development can be affected and can have repercussions for later development. Studies in adults with neurological injuries (e.g., stroke, spinal cord injury) have shown that it is important to start intensive therapy soon after the injury, and it may be true that starting intensive therapy at a young age will be helpful for children with cerebral palsy. Researchers are interested in testing the effectiveness of a special body weight support system for mobility training in young children who have or are at risk for cerebral palsy. Objectives: \- To study the effectiveness of a mobility training program on the motor skills of young children who have or are at risk for cerebral palsy. Eligibility: \- Children between 12 and 36 months of age who have delayed motor skills and either have been diagnosed with cerebral palsy or show evidence of spasticity or brain damage. Design: * This study involves two 6-week study phases: a baseline phase and a mobility training program. * Participants will be screened with a physical examination and medical history. * During the baseline phase, participants will have mobility testing sessions once every 2 weeks. These tests will measure motor development and ability, including ease and speed of walking. * Participants' parents/guardians will receive a mobility sensor for the child to wear at home for at least 6 hours (awake time) to measure activity and mobility levels outside of the testing sessions. * After 6 weeks of baseline testing, participants will have 6 weeks of mobility training for 30 minutes 3 days per week. Training will involve motor tasks with weight support, conducted by a pediatric physical therapist. Activities may include walking, climbing inclines or steps, or squatting to reach toys. All session
Interventions
- BEHAVIORAL mobility training with dynamic body weight support
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-11-15 |
| Est. Completion | 2014-06-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01253083
The ClinicalTrials.gov registry entry for NCT01253083 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which mobility training with dynamic body weight support is the first listed.
NCT01253083 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01253083 about?
NCT01253083 is a clinical study titled "Mobility Training to Improve Motor Behavior in Toddlers With or at Risk for Cerebral Palsy: A Pilot Study". Background: \- People who have cerebral palsy often have difficulty walking and moving their legs. Cerebral palsy is sometimes not identified until a child is almost 2 years of age, which means that early motor skill development can be affected and can have repercussions for later development. Stud...
What is the current status of trial NCT01253083?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2010-11-15. Estimated completion is 2014-06-06.
What interventions are being tested in trial NCT01253083?
The interventions under investigation include: mobility training with dynamic body weight support (BEHAVIORAL).
Who is sponsoring clinical trial NCT01253083?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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