Using wearable technology to improve rehabilitation for mild traumatic brain injury
Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation
This study is testing whether using wearable technology to give real-time feedback during balance exercises can help people with mild traumatic brain injuries recover better than standard rehabilitation methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 3 sites (Portland, Oregon and 2 other locations) |
| Trial ID | NCT06381674 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the assessment and treatment of mild traumatic brain injury (mTBI) by utilizing wearable sensors that provide real-time biofeedback during vestibular rehabilitation. Participants will receive immediate visual and auditory feedback on their movement quality while performing balance and walking exercises, which may lead to improved rehabilitation outcomes. The study will compare this innovative approach against standard vestibular rehabilitation methods to evaluate its effectiveness. By focusing on the specific subtypes of mTBI that affect balance and gait, the research seeks to tailor rehabilitation to individual patient needs.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-60 who have been diagnosed with mTBI and are experiencing ongoing symptoms related to balance and vision.
Not a fit: Patients with other medical or neurological conditions that could explain their balance or vision deficits may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve rehabilitation outcomes for patients with mTBI, particularly those experiencing balance impairments.
How similar studies have performed: While the use of wearable technology in rehabilitation is gaining traction, this specific approach to mTBI treatment is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * For all Aims, participants may be either civilians, active duty military, or Veterans, and must: 1. have a diagnosis of mTBI based on VA/DoD criteria 2. be between 18-60 years old, 3. be able to stand unassisted for 10 minutes at a time 4. be outside of the acute stage (\> 2 weeks post-concussion) but within 6 months of their most recent mTBI and still reporting symptoms 5. have at least some measurable deficit in Vestibular/Ocular categories based on Concussion Profile Screen 6. have sufficient vision (corrected or uncorrected) for unassisted reading and performance of everyday personal tasks and independent community ambulation 7. have adequate hearing (without amplification) adequate for engaging in close-range personal or telephone conversation. Exclusion Criteria: * Participants must not: 1. have had or currently have any other injury, medical, or neurological illness that could potentially explain balance or vision deficits (e.g., CNS disease, stroke, epilepsy, greater than mild TBI, Meniere's, bilateral vestibular loss, recent lower extremity or spine orthopedic injury that impairs mobility) this includes unresolved symptoms from previous concussions 2. meet criteria for moderate to severe substance-use disorder within the past month, as defined by DSM-V 3. display behavior that would significantly interfere with the validity of data collection or safety during the study 4. be in significant pain during the evaluation (\> 7/10 by patient subjective report) 5. be a pregnant female (balance considerations) 6. been hospitalized for any brain injuries (separate from the emergency department) 7. have significant joint pain or recent musculoskeletal injury that limits walking or mobility 8. have had any major surgeries in the past year or amputation 9. use an assistive device 10. unable to stand barefoot 11. currently receiving rehabilitation services for their mTBI or injuries related to their concussion (if rehabilitation has been completed more than 1 month ago participants may still be included).
Where this trial is running
Portland, Oregon and 2 other locations
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- Fort Sam Houston — San Antonio, Texas, United States (Not_yet_recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Laurie A King, PhD, DPT — Oregon Health and Science University
- Study coordinator: Laurie A King, PhD, PT, MCR
- Email: kingla@ohsu.edu
- Phone: 503-418-2602
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.