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

Recruiting now · Not applicable

Conditions studied: Mild Traumatic Brain Injury, Concussion, Rehabilitation, Balance Impairment

In brief

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 facts

Study ID: NCT06381674
Run by: Oregon Health and Science University
People needed: 100
Starts: 2024-06-13
Expected to finish: 2028-09-30
Last updated by the study team: 2025-10-14

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

For all Aims, participants may be either civilians, active duty military, or Veterans, and must:
have a diagnosis of mTBI based on VA/DoD criteria
be between 18-60 years old,
be able to stand unassisted for 10 minutes at a time
be outside of the acute stage (> 2 weeks post-concussion) but within 6 months of their most recent mTBI and still reporting symptoms
have at least some measurable deficit in Vestibular/Ocular categories based on Concussion Profile Screen
have sufficient vision (corrected or uncorrected) for unassisted reading and performance of everyday personal tasks and independent community ambulation
have adequate hearing (without amplification) adequate for engaging in close-range personal or telephone conversation.

You may not qualify if…

Participants must not:
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
meet criteria for moderate to severe substance-use disorder within the past month, as defined by DSM-V
display behavior that would significantly interfere with the validity of data collection or safety during the study
be in significant pain during the evaluation (> 7/10 by patient subjective report)
be a pregnant female (balance considerations)
been hospitalized for any brain injuries (separate from the emergency department)
have significant joint pain or recent musculoskeletal injury that limits walking or mobility
have had any major surgeries in the past year or amputation
use an assistive device
unable to stand barefoot
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 it is running

Oregon Health & Science University — Portland, Oregon, United States (enrolling)
University of Utah — Salt Lake City, Utah, United States (enrolling)
Fort Sam Houston — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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