Status:
TERMINATED
Treadmill Training at Constant or Different Speeds for People With Traumatic Brain Injury
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Traumatic Brain Injury
Walking Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 we...
Detailed Description
Objectives: To test the effectiveness of using time varying walking velocity in Body-Weight Supported Treadmill Training (BWSTT) as compared to using constant velocity in subjects with Traumatic Brain...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects eligible for participation in this research study must meet the following inclusion criteria:
- Diagnosis of non-penetrating TBI, specifically functionally mild to moderate TBI (those individuals who demonstrate the ability or capacity to ambulate)
- Injury occurred at least 6 months prior to enrollment
- Age of 18 or older
- Able to stand and walk on a treadmill for 30 minutes (with some breaks in the middle)
- Have mild or moderate functional gait impairment (score 1 or 2 in the first two tests in DGI: 1. Gait Level Surface test and 2. Change in Gait Speed test)
- Able to provide informed consent
- Able to read 3 inch by 3 inch letters in the monitor located at 1 meter distance from the treadmill without affecting gait patterns on the treadmill.
- EXCLUSION CRITERIA:
- 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
Exclusion
Key Trial Info
Start Date :
July 29 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2014
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01419522
Start Date
July 29 2011
End Date
January 6 2014
Last Update
December 16 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892