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

NCT01419522 | Terminated Phase 3

• 2 other identifiers: 11020311-CC-0203
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Walking Impairment; Gait Training

Keywords

Traumatic Brain Injury; Walking Impairment; Gait Training; TBI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

Gait Training Method OTHER

Treadmill training at constant velocity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Campbell M, Parry A. Balance disorder and traumatic brain injury: preliminary findings of a multi-factorial observational study. Brain Inj. 2005 Dec;19(13):1095-104. doi: 10.1080/02699050500188898.

  PMID: 16286323 BACKGROUND

• Katz-Leurer M, Rotem H, Lewitus H, Keren O, Meyer S. Relationship between balance abilities and gait characteristics in children with post-traumatic brain injury. Brain Inj. 2008 Feb;22(2):153-9. doi: 10.1080/02699050801895399.

  PMID: 18240044 BACKGROUND

• Kerrigan DC, Bang MS, Burke DT. An algorithm to assess stiff-legged gait in traumatic brain injury. J Head Trauma Rehabil. 1999 Apr;14(2):136-45. doi: 10.1097/00001199-199904000-00004.

  PMID: 10191372 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Diane L Damiano, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 17, 2011
• First Posted: August 18, 2011
• Study Start: July 29, 2011
• Primary Completion: January 6, 2014
• Study Completion: January 6, 2014
• Last Updated: December 16, 2019

Record last verified: 2014-01-06

Locations

US (1)