High Intensity Step Training After Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— B-HIST  

Official title:

Improving Balance and Mobility After Traumatic Brain Injury: A Randomized Controlled Trial Evaluating High Intensity Step Training

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05702138
• Other study ID #: IRB#1947316-1
• Status: Recruiting
• Phase: Phase 2
• Start date: March 20, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: December 2023
• Source: Craig Hospital
• Contact: Marissa Lundstern, MPH
• Phone: 303-789-8970
• Email: mlundstern[@]craighospital.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will explore whether the types and intensity of the interventions being delivered will yield measurable cognitive benefits in addition to improved mobility and balance. The study evaluates three therapeutic approaches to improve mobility and balance after traumatic brain injury (TBI): Conventional Gait and Balance Training, high intensity step training, and high intensity step training with virtual reality.

Description:

Individuals with traumatic brain injury (TBI) walk more slowly, demonstrate greater imbalance, and have reduced endurance. There is strong evidence that a single bout of physical activity has substantial cognitive benefits among older adults and stroke survivors, yet similar studies have not been conducted in TBI. This study will explore whether the types and intensity of the interventions being delivered will yield measurable cognitive benefits in addition to improved mobility and balance. The study evaluates three therapeutic approaches to improve mobility and balance after TBI: the first approach, Conventional Gait and Balance Training (CGBT), represents the current approach for walking retraining. CGBT focuses on walking training in a variety of conditions, obstacle management training, functional independence training, strength training, and standing dynamic balance training. The second approach, high intensity step training (HIST), focuses on the repetition of stepping at higher cardiovascular intensities and yielding a greater number of steps per training session with promising evidence already published in stroke and spinal cord injury (SCI). The third approach combines virtual reality with HIST, designed to increase cortical excitability while concurrently activating the neuromuscular system.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: August 31, 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• TBI definition: damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness (LOC) or post traumatic amnesia (PTA) due to brain trauma or by objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination
• Less than 6 months post injury at time of consent
• Weight less than 298 pounds and height less than 6'2" (based on treadmill contraindications)
• Intact skin (no open lesions/bandages) in the area of treadmill harness contact
• Able to walk ten feet requiring the physical assistance of not more than two people and/or bracing, assistive devices
• Impaired walking speed of < than 1.4 meters/second
• Ability to follow directions/standardized instructions
• Minimum 18 years of age at consent
• Completing or have completed initial inpatient rehabilitation for TBI
• O-Log score of at least 20
• Medically cleared for HIST by a physician

Exclusion Criteria:

• Uncontrolled cardiopulmonary, metabolic, or infectious disorder
• History of orthopedic or additional neurological disorder that limited motor function before TBI
• Any reason that, in the opinion of the study investigators or medical team, would interfere with completing the study protocol such as behavioral concerns
• Uncontrolled seizure disorder
• Pregnant or lactating females
• Current participation in any other interventional trials
• History of an untreated or a poorly controlled psychiatric condition such as depression, schizophrenia, or bipolar disorder

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Physical therapy
The study evaluates three physical therapeutic approaches to improve mobility and balance after traumatic brain injury (TBI).

Locations

Country	Name	City	State
United States	Craig Hospital	Englewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Craig Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognition	Brief Test of Adult Cognition by Telephone (BTACT):	6 Weeks
Primary	Walking Speed	10 Meter Walk Test (10MWT)	6 Weeks
Secondary	Walking Endurance	6 Minute Walk Test (6MWT)	6 Weeks
Secondary	Balance	Functional Gait Assessment and Berg Balance Scale (FGA) and (BBS)	6 Weeks
Secondary	Participant Enjoyment	Physical Activity Enjoyment Scale	6 Weeks