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

NCT06381674 | Recruiting

• 2 other identifiers: OHSU: 25890HT9425-23-1-0845
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Patient Global Impression of Change (PGIC)

  This single questionnaire will ask the participant to rate how they perceive their health has changed over the course of treatment. This scale is 1-7 where 1 is no change in quality of life and 7 is a great change that has made all the difference.

  Week 8 of study

Secondary Outcomes (26)

• Concussion Clinical Profiles Screening (CP Screening)

  Weeks 1 and 8 of study

• Dizziness Handicap Index (DHI)

  Weeks 1 and 8 of study

• Quality of Life After Brain Injury (QOLIBRI)

  Weeks 1 and 8 of study

• The Patient Reported Outcomes Measurement Information System (PROMIS)-Satisfaction with Participation in Social Roles-Short Form 4a

  Weeks 1 and 8 of study

• Hospital Anxiety and Depression Scale (HADS)

  Weeks 1 and 8 of study

Study Arms (2)

Vestibular Therapy Augmented with Audio and Visual Real-Time Biofeedback

EXPERIMENTAL

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.

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

Vestibular Therapy-Standard of Care

ACTIVE COMPARATOR

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

Other: Vestibular therapy for mTBI

Interventions

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

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.

Also known as: Rehabilitation

Vestibular Therapy Augmented with Audio and Visual Real-Time Biofeedback

Vestibular therapy for mTBI OTHER

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

Also known as: Rehabilitation

Vestibular Therapy-Standard of Care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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).

Sponsors & Collaborators

• Oregon Health and Science University: lead
• United States Department of Defense: collaborator

Study Sites (3)

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

RECRUITING

Fort Sam Houston

San Antonio, Texas, 78234, United States

NOT YET RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Publications (102)

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MeSH Terms

Conditions

Brain Concussion

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Laurie A King, PhD, DPT

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie A King, PhD, PT, MCR

CONTACT

503-418-2602; kingla@ohsu.edu

Maggie E Stojak, MS

CONTACT

971-420-4351; stojak@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Parties that will be masked include those collecting and analyzing data before and after rehabilitation (post-doctorate fellows, research assistants, and statistician).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There will be two groups in this study that will be randomized concurrently into two different rehabilitation programs.

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 24, 2024
• Study Start: June 13, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (3)