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Recruiting Phase 2 NCT05702138

High Intensity Step Training After Traumatic Brain Injury

Trial Parameters

Condition Traumatic Brain Injury
Sponsor Craig Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 111
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-03-20
Completion 2026-12
Interventions
Physical therapy

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.

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: * Uncontro

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