Improving Balance and Mobility After Traumatic Brain Injury: A Randomized Controlled Trial Evaluating High Intensity Step Training

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Colorado
Craig Hospital
RECRUITING
Englewood
Contact Information
Primary
Marissa Lundstern, MPH
mlundstern@craighospital.org
303-789-8970
Backup
Kaitlin Hays, DPT
khays@craighospital.org
Time Frame
Start Date: 2023-03-20
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 111
Treatments
Active_comparator: Conventional Gait and Balance Training (CGBT)
The current approach for walking retraining, Conventional Gait and Balance Training (CGBT) focuses on walking training in a variety of conditions, obstacle management training, functional independence training, strength training, and standing dynamic balance training.
Experimental: High Intensity Step Training (HIST)
High Intensity Step Training (HIST) focuses on the repetition of stepping at higher cardiovascular intensities and yielding a greater number of steps per training session.
Experimental: High Intensity Step Training with Virtual Reality (HISTVR)
The third arm combines virtual reality with HIST, designed to increase cortical excitability while concurrently activating the neuromuscular system.
Related Therapeutic Areas
Sponsors
Leads: Craig Hospital

This content was sourced from clinicaltrials.gov