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RECRUITING

NCT06381674

Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation

Sponsor: Oregon Health and Science University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-06-13

Completion Date

2028-09-30

Last Updated

2025-10-14

Healthy Volunteers

Conditions

Mild Traumatic Brain Injury, Concussion Rehabilitation Balance Impairment

Interventions

OTHER

Vestibular therapy for mTBI augmented with audio and visual real-time biofeedback

During physical therapy sessions participants will wear sensors on their head, chest, waist, and feet for real-time instrumented audio and visual biofeedback on quality of therapeutic exercise.

OTHER

Vestibular therapy for mTBI

During physical therapy sessions participants will go through vestibular therapeutic exercise WITHOUT audio and visual real-time biofeedback.

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).

Locations (3)

Oregon Health & Science University

Portland, Oregon, United States

Fort Sam Houston

San Antonio, Texas, United States

University of Utah

Salt Lake City, Utah, United States