High Intensity Step Training After Traumatic Brain Injury

NCT ID: NCT05702138

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2027-08-31

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Physical therapy

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Physical therapy

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Physical therapy

Intervention Type: OTHER

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

Interventions

Physical therapy

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Craig Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Candy Tefertiller, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

Craig Hospital

Locations

Craig Hospital

Englewood, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Marissa Lundstern, MPH

Role: CONTACT

mlundstern@craighospital.org

303-789-8970

Kaitlin Hays, DPT

Role: CONTACT

khays@craighospital.org

Facility Contacts

Marissa Lundstern, MPH

Role: primary

mlundstern@craighospital.org

303-789-8970

Katie Hays, DPT

Role: backup

khays@craighospital.org

303-789-8000

Other Identifiers

IRB#1947316-1

Identifier Type: -

Identifier Source: org_study_id