Treadmill Training at Constant or Different Speeds for People With Traumatic Brain Injury
Stopped early · Phase 3
Conditions studied: Traumatic Brain Injury, Walking Impairment, Gait Training
In brief
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.
Key facts
- Study ID
- NCT01419522
- Run by
- National Institutes of Health Clinical Center (CC)
- People needed
- 1
- Starts
- 2011-07-29
- Expected to finish
- 2014-01-06
- Last updated by the study team
- 2019-12-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Subjects are not eligible for participation in this research study if any of the following conditions exist:
- Taking medications that affect motor function such as baclofen, levodopa, benzodiazepams, tizanadine, or dantrolene sodium.
- Had surgery to either lower limb within the last year or requires surgery during the period of the study
- Had botulinum toxin injections in lower limbs within the last 4 months or willing to forego botulinum toxins in lower limbs for the duration of the study
- Are currently receiving any type of gait training or similar intervention outside of the study or unwilling to forego initiation of such an intervention during the period of this study
- Presence of severe pain in the lower limbs (VAS 5 or above)
- Medical or psychological instability such that the clinician judges that the subject is unsafe to enroll in the study or the subject cannot answer questions or follow instructions to fulfill the study
- Any known cardiac or pulmonary disease
- A woman with pregnancy
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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