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

This study has been terminated.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01419522
First received: August 17, 2011
Last updated: June 27, 2014
Last verified: January 2014
  Purpose

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.

Condition Intervention Phase
Traumatic Brain Injury
Walking Impairment
Gait Training
Other: Gait Training Method
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Effect of Time Varying Walking Velocity in Body-Weight Supported Treadmill Training

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 1
Study Start Date: July 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Gait Training Method
    Treadmill training at constant velocity
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419522

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Diane L Damiano, Ph.D. National Institutes of Health Clinical Center (CC)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01419522     History of Changes
Other Study ID Numbers: 110203, 11-CC-0203
Study First Received: August 17, 2011
Last Updated: June 27, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Traumatic Brain Injury
Walking Impairment
Gait Training
TBI

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 29, 2014