Treadmill Training at Constant or Different Speeds for People With Traumatic Brain Injury

Phase 3

Terminated

• Conditions: Traumatic Brain Injury; Walking Impairment; Gait Training

• Registration Number: NCT01419522
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

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 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.

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 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.

Study Timeline

• Study Start: 2011-07-29
• Study First Submitted: 2011-08-17
• Study First Submitted QC: 2011-08-17
• Study First Posted: 2011-08-18
• Status Verified: 2014-01-06
• Primary Completion: 2014-01-06
• Study Completion: 2014-01-06
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States