Actively Recruiting
Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation
Led by Oregon Health and Science University ยท Updated on 2025-10-14
100
Participants Needed
3
Research Sites
224 weeks
Total Duration
On this page
Sponsors
O
Oregon Health and Science University
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Current clinical assessment tools are often not sensitive enough to detect and treat some subtle (yet troubling) problems after mTBI. In this study, the investigators will use wearable sensors to both assess and treat people with mTBI. Specifically, the investigators will provide immediate feedback, with visual and/or auditory, on movement quality during physical therapy. This immediate feedback on performance may improve outcomes as the investigators will measure multiple body segments including head movements simultaneously with balance and walking exercises. Such complex movements are needed for safe return to high level activity and military duty. The investigators will test this approach against a standard vestibular rehabilitation program. There are few potential risks to this study such as increasing symptoms and a small fall risk. Benefits include physical therapy for balance problems regardless of therapy with or without biofeedback. An indirect benefit is to have data on correct dosage of physical therapy. The investigators will also distinguish which concussion subtype profiles benefit most from physical therapy. This will help healthcare providers and patients by providing more information to help establish clinical guidelines and new tools for physical therapy.
CONDITIONS
Official Title
Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with mild traumatic brain injury based on VA/DoD criteria
- Age between 18 and 60 years
- Able to stand unassisted for 10 minutes
- More than 2 weeks and less than 6 months since most recent mTBI with ongoing symptoms
- Have measurable vestibular or ocular-motor deficits based on Concussion Profile Screen
- Have sufficient vision (corrected or uncorrected) for reading and daily tasks
- Have adequate hearing for close-range or telephone conversation without amplification
You will not qualify if you...
- Have other injuries or medical conditions that could explain balance or vision problems (e.g., CNS disease, stroke, epilepsy, moderate/severe TBI, Meniere's disease, bilateral vestibular loss, recent orthopedic injury)
- Meet criteria for moderate to severe substance-use disorder in the past month
- Display behavior interfering with data validity or safety in the study
- Experience significant pain (>7/10) during evaluation
- Are pregnant females
- Have been hospitalized for brain injuries (beyond emergency department)
- Have significant joint pain or recent musculoskeletal injury limiting mobility
- Have had major surgeries or amputations in the past year
- Use assistive devices
- Are unable to stand barefoot
- Currently receiving rehabilitation services for mTBI or related injuries (unless completed more than 1 month ago)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Actively Recruiting
2
Fort Sam Houston
San Antonio, Texas, United States, 78234
Not Yet Recruiting
3
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
L
Laurie A King, PhD, PT, MCR
CONTACT
M
Maggie E Stojak, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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