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NCT Number: NCT05702138

High Intensity Step Training After Traumatic Brain Injury

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Therapy

Other

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

Primary outcomes

  1. Walking Speed

    Time frame: 6 Weeks

    10 Meter Walk Test (10MWT)

Secondary outcomes

  1. Walking Endurance

    Time frame: 6 Weeks

    6 Minute Walk Test (6MWT)

  2. Balance

    Time frame: 6 Weeks

    Functional Gait Assessment and Berg Balance Scale (FGA) and (BBS)

  3. Participant Enjoyment

    Time frame: 6 Weeks

    Physical Activity Enjoyment Scale

Other outcomes

  1. Cognition

    Time frame: 6 Weeks

    Brief Test of Adult Cognition by Telephone (BTACT):

Study contacts

Contact information is provided by the study sponsor or research team.

Kaitlin Hays, DPT

CONTACT

[email protected]

Marissa Lundstern, MPH

CONTACT

[email protected]

303-789-8970

Sponsors and collaborators

Lead sponsor

Craig Hospital

Other

Registry information

Official study title

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

Acronym: B-HIST

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 27, 2023
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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