A Phase 3 interventional study of Gait Training Method in Traumatic Brain Injury, Walking Impairment and Gait Training, sponsored by National Institutes of Health Clinical Center (CC). Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-16.
Sponsored by National Institutes of Health Clinical Center (CC) · Phase 3, Interventional, and Treatment
Background:
Objectives:
Eligibility:
Design:
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 Injury (TBI). We hypothesize that using time varying velocity will result in a greater improvement in ambulatory function.
Study Population: 30 adult subjects with a clinical diagnosis of non-penetrating TBI and with functional deficits in gait will be enrolled. Subjects will be recruited from NIH, affiliated hospitals/clinics, and in the community.
Design: This pilot study will use an instrumented treadmill (Bertec Co., Columbus, Ohio) and a force controlled harness system called ZeroG (Aretech LLC, Ashburn, Virginia). Subjects will be randomly assigned to one of two groups (12 subjects per group): the first group will receive BWSTT at a constant velocity (also known as standard treadmill training); and the second group will receive BWSTT at randomized time varying velocity. BWSTT at time varying velocity consists of two components: 1) subjects passively adjusting their walking speed to the continuously changing speed of the treadmill; and 2) subjects actively changing their walking speed by following the instructed walking speed displayed on a monitor screen while the treadmill is automatically adjusted to the subjects speed. Each group will receive 8 gait training sessions (30 minutes per session, twice per week) for four weeks. Gait performance will be tested before (pre-test) and after (post-test) the 8 session gait training program.
Outcome Measures: The primary outcome measures are parameters representing gait performance: maximum walking speed, self-selected walking speed, cadence, stride length, percentage of swing, stance and double stance periods, gait symmetry, Time Up and Go (TUG), and Dynamic Gait Index (DGI) scores. The secondary outcome measure is physical and cognitive effort exerted during the training session as evaluated by grip-strength test and LNS (Letter-Number Sequencing) test.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 1 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
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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
Treadmill training at constant velocity
The primary outcome measures are parameters representing gait performance such as maximum/self-selected walking speed, cadence, stride length, Time Up and Go test scores and Dynamic Gait Index scores.
The secondary outcome measures are physical and cognitive effort exerted during the training. Physical effort will be measured by grip strength. Cognitive effort will be estimated by Letter Number Sequence test.
This study is terminated, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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National Institutes of Health Clinical Center (CC)