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NCT01419522 · ClinicalTrials.gov registry record · Phase 3
Treadmill Training at Constant or Different Speeds for People With Traumatic Brain Injury
A Phase 3 study, sponsored by National Institutes of Health Clinical Center (CC).
- Terminated
- Registry status
- Phase 3
- Development phase
- 1
- Enrollment target
NCT01419522 is a Phase 3 study that was terminated before completion, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 1 participants.
The verdict
NCT01419522, a Phase 3 study, was terminated before completion, sponsored by National Institutes of Health Clinical Center (CC).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1 participants
- Enrollment target
Study Summary
Background: \- Many people who have had a traumatic brain injury have difficulty walking. Training on a treadmill is often used to help people with walking difficulties. Supporting a person s body weight with a harness while using the treadmill can help improve walking skills in people with brain injury. Varying the rate at which people walk on the treadmill may also help more than walking at a constant rate. Treadmill training with body weight support or walking at different speeds may improve walking skills in people who have had a traumatic brain injury. More research is needed to see if one method is better than the other. Objectives: \- To compare the effects of two types of treadmill training in people who have had a traumatic brain injury. Eligibility: \- People at least 18 years of age who have had a mild or moderate traumatic brain injury at least 6 months ago and have mild or moderate walking difficulty. Design: * Participants will be screened with a medical history and physical exam. They will also take a basic walking test (not on a treadmill). * Participants will be divided into two groups. The first group will have treadmill training at a constant speed. The second group will have treadmill training at different speeds. All participants will wear a support harness while walking on the treadmill. * At the first training visit, participants will have a gait assessment with different tests of walking. Then they will have a treadmill walking session. * After the first visit, participants will return twice a week for 6 weeks for treadmill training sessions (visits 3 through 12). They will also have grip strength and walking tests. * At the end of 6 weeks, participants will have a final treadmill training session, and will have a gait assessment exactly like the one in the first training visit. * At 6 months after the final session, participants will have a followup visit with a final gait assessment.
Interventions
- OTHER Gait Training Method
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2011-07-29 |
| Est. Completion | 2014-01-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01419522
The ClinicalTrials.gov registry entry for NCT01419522 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1 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 Gait Training Method is the first listed.
NCT01419522 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01419522 about?
NCT01419522 is a clinical study titled "Treadmill Training at Constant or Different Speeds for People With Traumatic Brain Injury". Background: \- Many people who have had a traumatic brain injury have difficulty walking. Training on a treadmill is often used to help people with walking difficulties. Supporting a person s body weight with a harness while using the treadmill can help improve walking skills in people with brain i...
What is the current status of trial NCT01419522?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2011-07-29. Estimated completion is 2014-01-06.
What interventions are being tested in trial NCT01419522?
The interventions under investigation include: Gait Training Method (OTHER).
Who is sponsoring clinical trial NCT01419522?
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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