Recruiting
Phase 2

High Intensity Step Training

Sponsor:

Craig Hospital

Code:

NCT05702138

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Physical therapy

Study Details

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.

Conditions

Traumatic Brain Injury

Study ID

NCT05702138

Start date

Mar 20, 2023

Status verified date

Feb, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

111 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Conventional Gait and Balance Training (CGBT)

The current approach for walking retraining, Conventional Gait and Balance Training (CGBT) focuses on walking training in a variety of conditions, obstacle management training, functional independence training, strength training, and standing dynamic balance training.

experimental: High Intensity Step Training (HIST)

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.

experimental: High Intensity Step Training with Virtual Reality (HISTVR)

The third arm combines virtual reality with HIST, designed to increase cortical excitability while concurrently activating the neuromuscular system.

Interventions

Physical therapy

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

Primary outcome measure

  • Walking Speed [ Time Frame: 6 Weeks ]

Central Contacts and Locations

Central contacts

Marissa Lundstern, MPH

303-789-8970mlundstern@craighospital.org

Kaitlin Hays, DPT

khays@craighospital.org

Locations

Craig Hospital

Recruiting

Englewood, Colorado, United States, 80113

Contacts

Marissa Lundstern, MPH

303-789-8970mlundstern@craighospital.org

Katie Hays, DPT

303-789-8000khays@craighospital.org

More Information

Sponsor

Craig Hospital

Last update posted

Feb 21, 2025

Last verified

Feb, 2025

Keywords

  • balance
  • mobility
  • physical therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Craig Hospital on 2025-02-21.