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High Intensity Step Training After Traumatic Brain Injury

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05702138
Acronym
B-HIST
Enrollment
111
Registered
2023-01-27
Start date
2023-03-20
Completion date
2027-08-31
Last updated
2025-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

balance, mobility, physical therapy

Brief 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.

Detailed 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.

Interventions

OTHERPhysical therapy

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

Sponsors

Craig Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Walking Speed6 Weeks10 Meter Walk Test (10MWT)

Secondary

MeasureTime frameDescription
Walking Endurance6 Weeks6 Minute Walk Test (6MWT)
Balance6 WeeksFunctional Gait Assessment and Berg Balance Scale (FGA) and (BBS)
Participant Enjoyment6 WeeksPhysical Activity Enjoyment Scale

Other

MeasureTime frameDescription
Cognition6 WeeksBrief Test of Adult Cognition by Telephone (BTACT):

Countries

United States

Contacts

Primary ContactMarissa Lundstern, MPH
mlundstern@craighospital.org303-789-8970
Backup ContactKaitlin Hays, DPT
khays@craighospital.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026