Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT06381674

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

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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