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Not Yet Recruiting NCT05702138

High Intensity Step Training After TBI

Conditions: Traumatic Brain Injury

Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 111
Sponsor: Craig Hospital

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 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 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 examinationLess than 6m post injury at time of consentWeight 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 contactAble to walk ten feet requiring the physical assistance of not more than one person and/or bracing, assistive devicesImpaired walking speed of < than 1.4 meters/secondAbility to follow directions/standardized instructionsMinimum 18 years of age at consentCompleting or have completed initial inpatient rehabilitation for TBIOut of PTA (> 25 O-Log score for three consecutive days)Medically cleared for HIST by a physicianExclusion Criteria:Uncontrolled cardiopulmonary, metabolic, or infectious disorderHistory of orthopedic or additional neurological disorder that limited motor function before TBIAny reason that, in the opinion of the study investigators or medical team, would interfere with completing the study protocol such as behavioral concernsUncontrolled seizure disorderPregnant or lactating femalesCurrent participation in any other interventional trialsHistory of an untreated or a poorly controlled psychiatric condition such as depression, schizophrenia, or bipolar disorder

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05702138). StuddyBuddy aggregates publicly available trial information.