High Intensity Step Training After Traumatic Brain Injury (B-HIST)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: Physical therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 111
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Marissa Lundstern, MPH; Phone Number: 303-789-8970; Email: mlundstern@craighospital.org
• Study Contact Backup: Name: Kaitlin Hays, DPT; Email: khays@craighospital.org

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Recruiting
      • Craig Hospital
      • Contact: Marissa Lundstern, MPH; Phone Number: 303-789-8970; Email: mlundstern@craighospital.org
      • Contact: Katie Hays, DPT; Phone Number: 303-789-8000; Email: khays@craighospital.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Physical therapy; The study evaluates three physical therapeutic approaches to improve mobility and balance after traumatic brain injury (TBI).
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.	Other: Physical therapy; The study evaluates three physical therapeutic approaches to improve mobility and balance after traumatic brain injury (TBI).
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.	Other: Physical therapy; The study evaluates three physical therapeutic approaches to improve mobility and balance after traumatic brain injury (TBI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking Speed	10 Meter Walk Test (10MWT)	6 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Enjoyment	Physical Activity Enjoyment Scale	6 Weeks
Walking Endurance	6 Minute Walk Test (6MWT)	6 Weeks
Balance	Functional Gait Assessment and Berg Balance Scale (FGA) and (BBS)	6 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognition	Brief Test of Adult Cognition by Telephone (BTACT):	6 Weeks

Collaborators and Investigators

• Sponsor: Craig Hospital
• Investigators: Principal Investigator: Candy Tefertiller, DPT, PhD, Craig Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: mobility; physical therapy; balance
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Wounds and Injuries; Brain Injuries
• Other Study ID Numbers: IRB#1947316-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No