High Intensity Step Training After Traumatic Brain Injury

NCT05702138 | Recruiting Phase 2

• 1 other identifier: IRB#1947316-1
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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

Keywords

balance; mobility; physical therapy

Outcome Measures

Primary Outcomes (1)

• Walking Speed

  10 Meter Walk Test (10MWT)

  6 Weeks

Secondary Outcomes (3)

• Walking Endurance

  6 Weeks

• Balance

  6 Weeks

• Participant Enjoyment

  6 Weeks

Other Outcomes (1)

• Cognition

  6 Weeks

Study Arms (3)

Conventional Gait and Balance Training (CGBT)

ACTIVE COMPARATOR

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

High Intensity Step Training (HIST)

EXPERIMENTAL

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

High Intensity Step Training with Virtual Reality (HISTVR)

EXPERIMENTAL

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

Other: Physical therapy

Interventions

Physical therapy OTHER

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

Conventional Gait and Balance Training (CGBT); High Intensity Step Training (HIST); High Intensity Step Training with Virtual Reality (HISTVR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Craig Hospital: lead

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Candy Tefertiller, DPT, PhD

  Craig Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marissa Lundstern, MPH

CONTACT

303-789-8970; mlundstern@craighospital.org

Kaitlin Hays, DPT

CONTACT

khays@craighospital.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: March 20, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

US (1)