Recruiting

Biofeedback-Based Rehabilitation

Sponsor:

Oregon Health and Science University

Code:

NCT06381674

Conditions

Mild Traumatic Brain Injury, Concussion

Rehabilitation

Balance Impairment

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

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

Vestibular therapy for mTBI

Study Details

Brief 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.

Conditions

Mild Traumatic Brain Injury, Concussion

Rehabilitation

Balance Impairment

Study ID

NCT06381674

Start date

Jun 13, 2024

Status verified date

Oct, 2025

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vestibular Therapy Augmented with Audio and Visual Real-Time Biofeedback

This arm will receive 12 sessions over 6-weeks of vestibular therapy for mTBI (concussion) based on clinical practice guidelines augmented with visual and audio real-time biofeedback.

active comparator: Vestibular Therapy-Standard of Care

This arm will receive 12 sessions of vestibular physical therapy over 6-weeks based on clinical practice guidelines for mTBI (concussion).

Interventions

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.

Vestibular therapy for mTBI

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

Primary outcome measure

  • Patient Global Impression of Change (PGIC) [ Time Frame: Week 8 of study ]

Central Contacts and Locations

Central contacts

Laurie A King, PhD, PT, MCR

503-418-2602kingla@ohsu.edu

Maggie E Stojak, MS

971-420-4351stojak@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239-3098

Contacts

Laurie A King, PhD, PT, MCR

503-418-2602kingla@ohsu.edu

Maggie E Stojak, MS

971-420-4351stojak@ohsu.edu

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Peter Fino, PhD

801-213-1363peter.fino@utah.edu

Lee Dibble, PhD, PT

lee.dibble@hsc.utah.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Keywords

  • mild traumatic brain injury (mTBI)
  • concussion
  • vestibular
  • ocular
  • balance
  • rehabilitation
  • biofeedback
  • wearable sensors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-10-14.