High intensity step training for improving mobility after brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of three therapeutic approaches to enhance mobility and balance in individuals with traumatic brain injury (TBI). The interventions include Conventional Gait and Balance Training, high intensity step training, and a combination of high intensity step training with virtual reality. The goal is to determine if these interventions can provide cognitive benefits alongside improvements in physical capabilities. Participants will engage in structured physical therapy sessions designed to assess their mobility and balance outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Craig Hospital
  Englewood, Colorado, United States Recruiting

Study contacts

• Principal investigator: Candy Tefertiller, DPT, PhD — Craig Hospital
• Study coordinator: Marissa Lundstern, MPH
• Email: mlundstern@craighospital.org
• Phone: 303-789-8970

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.