High Intensity Step Training After Traumatic Brain Injury

Recruiting now · Phase 2

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT05702138

Run by

Craig Hospital

People needed

111

Starts

2023-03-20

Expected to finish

2027-08-31

Last updated by the study team

2025-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Craig Hospital — Englewood, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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