High intensity step training for improving mobility after brain injury
Improving Balance and Mobility After Traumatic Brain Injury: A Randomized Controlled Trial Evaluating High Intensity Step Training
This study is testing different types of training, including high intensity step training and virtual reality, to see if they can help people with brain injuries improve their mobility and balance.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 111 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Craig Hospital Academic / other |
| Locations | 1 site (Englewood, Colorado) |
| Trial ID | NCT05702138 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are less than six months post-injury and have experienced a traumatic brain injury with specific mobility impairments.
Not a fit: Patients who are more than six months post-injury or have severe mobility limitations requiring more than two people for assistance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mobility, balance, and cognitive function for patients recovering from traumatic brain injury.
How similar studies have performed: Previous studies have shown promising results with high intensity training in stroke and spinal cord injury populations, suggesting potential for success in this novel application for TBI.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Englewood, Colorado
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.