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Mild Traumatic Brain Injury, ConcussionSuBTyPENCT06381674

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

A study testing Vestibular therapy for mTBI augmented with audio and visual real-time biofeedback and Vestibular therapy for mTBI in people with Mild Traumatic Brain Injury, Concussion and Rehabilitation, run by Oregon Health and Science University at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Vestibular therapy for mTBI augmented with audio and visual real-time biofeedback and Vestibular therapy for mTBI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesUnited States
Study dates
13 Jun 2024to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 12Show fewer
  • 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).

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Laurie A King, PhD, PT, MCR contact

503-418-2602

kingla@ohsu.edu

Maggie E Stojak, MS contact

971-420-4351

stojak@ohsu.edu

United States3 sites, 3 recruiting
  • Oregon Health & Science University

    Portland, Oregon, 97239-3098

    Laurie A King, PhD, PT, MCR, 503-418-2602, kingla@ohsu.edu

    Maggie E Stojak, MS, 971-420-4351, stojak@ohsu.edu

    Recruiting
  • University of Utah

    Salt Lake City, Utah, 84112

    Peter Fino, PhD, 801-213-1363, peter.fino@utah.edu

    Lee Dibble, PhD, PT, lee.dibble@hsc.utah.edu

    Recruiting
  • Fort Sam Houston

    San Antonio, Texas, 78234

    Angela Weston, PhD, PT

    Not yet recruiting

Other trials in United States

About this study

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.

Read the detailed description

Mild traumatic brain injury (mTBI) is common and can cause long-term problems. Balance problems are one of the most common problems and can prevent people from returning to their previous quality of life. People with mTBI can have many symptoms that present differently (i.e., 'subtypes'), making it difficult to evaluate and treat. Subtypes include cognitive, ocular-motor (vision problems), headache, vestibular (balance and dizziness) and mood. Correct detection of subtypes is important for patients to get the best and most specific (to their subtype) care, as quickly as possible. Our group has expertise in the subtypes that could likely affect balance and gait (vestibular and ocular-motor; V/O) and investigators plan to use wearable sensors and objective measures to improve detection and treatment of the problems that commonly occur in these subtypes. The investigators will test an approach (multi-segmental biofeedback) using wearable sensors that can measure how people move overall and can provide immediate feedback on how multiple body segments move during vestibular rehabilitation. Specifically, these sensors can provide feedback on head and body movement and speed but also measure how stable balance and walking are during an exercise. The investigators believe real-time feedback during the exercises will improve the quality of rehabilitation, specifically for those patients with V/O subtypes. The investigators also want to explore whether people with V/O subtypes move differently in the real world. The investigators will do this by measuring daily life mobility over 7 days using wearable sensors.

The Aims of this project are:

  1. Aim I. Multidimensional, real-time biofeedback for rehabilitation: To determine if multidimensional real-time biofeedback using novel wearable technology that measures head/trunk and balance/gait improves outcomes after rehabilitation compared to standard care. For this aim, the investigators will enroll 100 participants (50 from Oregon Health \& Science University and 50 from University of Utah). People will be randomized into either vestibular physical therapy augmented with visual/audio real-time biofeedback or into vestibular therapy without real-time biofeedback. Participants will be tested before and after a 6-week (2x/week) rehabilitation program. Our primary outcome will be the Patient Global Impression of Change (PGIC). Secondary outcomes will include Subjective Patient-reported, Clinical Assessment, and Instrumented Assessment measures.
  2. Responsiveness to rehabilitation; objective measures to identify V/O subtype. Aim II is a separate analysis based on the data collected in Aim I. For this Aim, the 100 participants from Aim 1 will be grouped according to severity of V/O symptoms. Here, the investigators will explore: a) the responsiveness to rehabilitation by level of V/O deficit and b) the strength of the relationship between Patient-reported and Clinical and Instrumented Assessments of V/O measures.
  3. Daily life mobility in people with V/O subtype: To: a) determine if daily life mobility (quality of gait and turning) is impacted differently in people with high V/O deficits and b) calculate healthy normative data for daily life mobility measures in active duty military service members. For Aim III, 50 people from Aim I, divided equally with V/O HI and V/O LO, will wear instrumented socks (APDM Wearable Technologies) over 7 days. Daily life mobility (quantity and quality) will also be collected on 40 healthy active duty service members over 7 days at Fort Sam Houston (FSH) to facilitate next steps in using continuous monitoring as an outcome measure after mTBI in the military.
Being tested
Vestibular therapy for mTBI augmented with audio and visual real-time biofeedback, Vestibular therapy for mTBI
Keywords
mild traumatic brain injury (mTBI), concussion, vestibular, ocular, balance, rehabilitation, biofeedback, wearable sensors
Medical subject headings
Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Rehabilitation

    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 mTBIOther

    Also called Rehabilitation

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

Study groups in NCT06381674
Study groupRoleWhat they receive
Vestibular Therapy Augmented with Audio and Visual Real-Time BiofeedbackExperimentalThis 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.
Receives: Other: Vestibular therapy for mTBI augmented with audio and visual real-time biofeedback
Vestibular Therapy-Standard of CareActive comparatorThis arm will receive 12 sessions of vestibular physical therapy over 6-weeks based on clinical practice guidelines for mTBI (concussion).
Receives: Other: Vestibular therapy for mTBI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 8 of study

Secondary outcomes (26)
  1. Concussion Clinical Profiles Screening (CP Screening)

    This is a 29-item scale that is organized around concussion clinical profiles: 1) anxiety/mood (5 items), 2) cognitive/fatigue (3 items), 3) migraine (5 items), 4) ocular (5 items), and 5) vestibular (5 items); and 2 modifiers: 1) sleep (4 items), and 2) neck (cervical) (2 items). Participants respond to each item on a 0 (none) to 3 (severe) Likert-type scale. The CP Screen provides a total symptom score ranging from 0 to 87 and individual subscale scores. A higher score indicates a higher severity of symptoms.

    Measured: Weeks 1 and 8 of study

  2. Dizziness Handicap Index (DHI)

    This is a 25-item self-assessment inventory that evaluates the self-perceived handicapping effects due to a vestibular disorder. For scoring, 16-34 points is mild handicap, 36-52 points is a moderate handicap, and 54+ points severe handicap.

    Measured: Weeks 1 and 8 of study

  3. Quality of Life After Brain Injury (QOLIBRI)

    This is a questionnaire with 37 items addressing 6 dimensions of quality of life; cognition, self, daily life and autonomy, social relationships, physical problems and feeling bothered by emotions.The questionnaire provides a profile of quality of life together with a total score. It is easy to fill in, and can be completed in 7-10 minutes. The scale means are converted to the 0-100 scale by subtracting 1 from the mean and then multiplying by 25. This produces scale scores which have a lowest possible value of 0 (worst possible quality of life) and a maximum value of 100 (best possible quality of life).

    Measured: Weeks 1 and 8 of study

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

    This is a questionnaire related to how satisfied participants are with social roles in the past 7 days. Higher scores mean more of the concept being measured. Example = more satisfaction.

    Measured: Weeks 1 and 8 of study

  5. Hospital Anxiety and Depression Scale (HADS)

    The HADS delineates potential anxiety or depression dominance where possible scores could range from 0 to 21 for anxiety and 0 to 21 for depression. Anxiety and depression are scored separately (8-10= mild, 11-14= moderate, 15-21= severe).

    Measured: Weeks 1 and 8 of study

  6. Headache Impact Test (HIT-6)

    This is a questionnaire that assesses the impact of headache severity on daily life activities. Higher scores indicate a greater impact on in the participant's life and the score range is 36-78. For example, a score of 36 is no impact on the participant's life and a score of 78 is always impacting the participant's life.

    Measured: Weeks 1 and 8 of study

  7. Insomnia Severity Index (ISI)

    This is 7-question survey that assess sleep problems. Respondents rate each element of the questionnaire using Likert-type scales. Responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia. Scores are tallied and can be compared both to scores obtained at a different phase of treatment and to the scores of other individuals. Though developers point out that their chosen cutoff scores have not been validated, they offer a few guidelines for interpreting scale results: a total score of 0-7 indicates no clinically significant insomnia, 8-14 means subthreshold insomnia, 15-21 is clinical insomnia (moderate severity), and 22-28 means clinical insomnia (severe).

    Measured: Weeks 1 and 8 of study

  8. Neck Disability Index (NDI)

    This questionnaire has 10 questions regarding neck pain during daily activities. Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability). All section scores are then totaled. Scoring is reported on a 0-50 scale, 0 being the best possible score and 50 being the worst. Alternately, the score can be reported from 0-100. The score is often reported as a percentage (0-100%).

    Measured: Weeks 1 and 8 of study

  9. Convergence Insufficiency Symptom Survey (CISS)

    This survey has 15 questions related to problems with convergence in everyday activities. Participants rate their symptoms on a 0-4 Likert Scale were 0 is never and 4 is always. A score of 21 or higher is suggestive of convergence insufficiency.

    Measured: Weeks 1 and 8 of study

  10. Vertigo Symptom Scale (VSS)

    The VSS contains 36 items addressing the frequency and severity of dizziness symptoms within the last 12 months. Frequency of symptoms is rated on a Likert scale: 0 points: "never", 1 point: "a few times (1-3 times a year)", 2 points: "several times (4-12 times a year)", 3 points: "quite often (on average, more than once a month)" and 4 points: "very often (on average more than once a week)". Total score aims to figure out the severity of dizziness where lower scores imply less severity. Two principle subscales are distinguishing between items related to vertigo and imbalance (Vertigo symptom scale) and those suggestive of anxiety and arousal (Autonomic/Anxiety).

    Vertigo/balance sub scale score range: 0-76 Autonomic/Anxiety subscale score range: 0-60

    Measured: Weeks 1 and 8 of study

  11. Automated Neuropsychological Assessment Metric (ANAM)

    This is a computerized neurocognitive test that takes about 20 minutes to complete. The ANAM collects information on attention, memory, or thinking ability.

    Measured: Weeks 1 and 8 of study

  12. Dynamic Visual Acuity ( DVA-Clinical)

    This test assesses gaze stability during head rotations relative to head-stationary visual acuity. The change in lines read compared to static acuity is noted. A loss of three or more lines of visual acuity relative to one's static visual acuity is regarded as clinically significant.

    Measured: Weeks 1 and 8 of study

  13. Ocular Motor Function Tests

    These tests will ask the participant to move their eyes in various directions.

    Measured: Weeks 1 and 8 of study

  14. Video Head Impulse Test (vHIT)

    This test will have the participant looking at a stationary object while their head is moved quickly.

    Measured: Weeks 1 and 8 of study

  15. Functional Gait Assessment (FGA)

    This assessment evaluates a patient's ability to adapt their balance while walking and undertaking a series of additional tasks such as turning their head, changing speeds, and stepping over an obstacle. Each item is scored on an ordinal scale from 0 to 3, with 0 = severe impairment, 1 = moderate impairment, 2 = mild impairment, 3 = normal ambulation and highest score = 30.

    Measured: Weeks 1 and 8 of study

  16. Complex Turning Course (CTC)

    This is a test of mobility that evaluates a person's ability to walk a prescribed path involving multiple turns of various angles.

    Measured: Weeks 1 and 8 of study

  17. Modified Balance Error Scoring System (mBESS)

    This test assesses balance by asking participants to stand in progressively challenging conditions (feet together, single limb stance and tandem) both on firm and foam surfaces. All items are performed with eyes closed. A rater evaluates the number of errors committed by the participant, such as opening their eyes or removing their hands from their hips during the first 20 seconds of the trial for each test. The total score can be between 0-30, where a higher score indicates more errors.

    Measured: Weeks 1 and 8 of study

  18. Modified Clinical Test for Sensory Integration on Balance (mCTSIB)

    This test assesses the sensory contributions to balance. In this test, participants stand with feet together in 4 conditions; 1) eyes open on a firm surface, 2) eyes closed on a firm surface, 3) eyes open on foam surface, and 4) eyes closed on a foam surface. Participants are clinician-rated on stability based on the ability to maintain balance for 30 seconds in each condition. If the subject cannot hold the position the test is stopped and the time is recorded for each trial. Completing 30 seconds for each trial is the optimal score. Total time is recorded, 120 seconds is optimal.

    Measured: Weeks 1 and 8 of study

  19. Instrumented One Minute Walk (Single and Dual Task)

    This is a measurement of over-ground walking performance over 1 minute with and without additional cognitive tasks.

    Measured: Weeks 1 and 8 of study

  20. Hybrid Assessment of Mobility (HAM-4)

    This test includes two components of the FGA (horizontal head turns and gait with pivot turn), as well as a fast walk forward and backward from the HiMAT. The highest possible score is 14. The higher the score, the higher the level of performance.

    Measured: Weeks 1 and 8 of study

  21. Tandem Gait (Single and Dual Task)

    This test will ask the participant to perform heel-to-toe walking without separating heel and toe as accurately and quickly as they can with and without additional cognitive tasks. Participants must complete the task without separating heel and toe or other deviations. Time will be recorded of the passing trials. A lower time indicates better performance.

    Measured: Weeks 1 and 8 of study

  22. Vestibular Ocular Motor Screening (VOMS)

    This test will look at a patient's symptom provocation with various head and eye movements. Baseline symptoms will be assessed 0-10 where 0 is no symptoms and 10 is the maximum severity of symptoms. After each test the subject will be asked to rate their symptoms 0-10. Total Score and change scores are calculated where high scores indicate more severe symptoms.

    Measured: Weeks 1 and 8 of study

  23. Central Sensorimotor Integration Testing (CSMI)

    The participant will be tested on a modified Research NeuroCom platform where they will stand on a force plate to record postural sway. The surface and/or visual surround will move while they will be instructed to maintain their balance. They will wear a safety harness attached above to prevent falling in case a loss of balance occurs.

    Measured: Weeks 1 and 8 of study

  24. Reactive Balance

    The participant will be tested on their reactive stepping in the anterior, posterior, and lateral directions.

    Measured: Weeks 1 and 8 of study

  25. Neurobehavioral Symptoms Inventory (NSI)

    This questionnaire has 22 questions and asks participants to rate how much a symptom disturbed them from 0 (none) to 3 (severe) over the past two weeks. The total score is the sum of responses.

    Measured: Weeks 1 and 8 of the study.

  26. International Physical Activity Questionnaire (IPAQ)

    This questionnaire assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.

    Measured: Weeks 1 and 8 of study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2024
  2. Study start13 Jun 2024
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
There will be two groups in this study that will be randomized concurrently into two different rehabilitation programs.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06381674
Sponsor's protocol ID
OHSU: 25890
Other IDs
HT9425-23-1-0845
Acronym
SuBTyPE
Status last verified
Oct 2025
First submitted
4 Apr 2024
Last updated
14 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • The Management and Rehabilitation of Post-Acute Mild Traumatic Brain Injury Work Group. VA/DoD Clinical Practice Guidelines for the Management of Concussion-Mild Traumatic Brain Injury. 2021:1-128.

  • Silverberg ND, Iaccarino MA, Panenka WJ, Iverson GL, McCulloch KL, Dams-O'Connor K, Reed N, McCrea M; American Congress of Rehabilitation Medicine Brain Injury Interdisciplinary Special Interest Group Mild TBI Task Force. Management of Concussion and Mild Traumatic Brain Injury: A Synthesis of Practice Guidelines. Arch Phys Med Rehabil. 2020 Feb;101(2):382-393. doi: 10.1016/j.apmr.2019.10.179. Epub 2019 Oct 23.

    PubMed 31654620
  • Coronado VG, McGuire LC, Sarmiento K, Bell J, Lionbarger MR, Jones CD, Geller AI, Khoury N, Xu L. Trends in Traumatic Brain Injury in the U.S. and the public health response: 1995-2009. J Safety Res. 2012 Sep;43(4):299-307. doi: 10.1016/j.jsr.2012.08.011. Epub 2012 Aug 25.

    PubMed 23127680
  • Corso P, Finkelstein E, Miller T, Fiebelkorn I, Zaloshnja E. Incidence and lifetime costs of injuries in the United States. Inj Prev. 2006 Aug;12(4):212-8. doi: 10.1136/ip.2005.010983.

    PubMed 16887941
  • Vanderploeg RD, Curtiss G, Luis CA, Salazar AM. Long-term morbidities following self-reported mild traumatic brain injury. J Clin Exp Neuropsychol. 2007 Aug;29(6):585-98. doi: 10.1080/13803390600826587.

    PubMed 17691031
  • Walker WC, Nowak KJ, Kenney K, Franke LM, Eapen BC, Skop K, Levin H, Agyemang AA, Tate DF, Wilde EA, Hinds S, Nolen TL. Is balance performance reduced after mild traumatic brain injury?: Interim analysis from chronic effects of neurotrauma consortium (CENC) multi-centre study. Brain Inj. 2018;32(10):1156-1168. doi: 10.1080/02699052.2018.1483529. Epub 2018 Jun 12.

    PubMed 29894203
  • McCrory P. Sports concussion and the risk of chronic neurological impairment. Clin J Sport Med. 2011 Jan;21(1):6-12. doi: 10.1097/JSM.0b013e318204db50.

    PubMed 21200164
  • Guskiewicz KM, McCrea M, Marshall SW, Cantu RC, Randolph C, Barr W, Onate JA, Kelly JP. Cumulative effects associated with recurrent concussion in collegiate football players: the NCAA Concussion Study. JAMA. 2003 Nov 19;290(19):2549-55. doi: 10.1001/jama.290.19.2549.

    PubMed 14625331
  • Kardouni JR, Shing TL, McKinnon CJ, Scofield DE, Proctor SP. Risk for Lower Extremity Injury After Concussion: A Matched Cohort Study in Soldiers. J Orthop Sports Phys Ther. 2018 Jul;48(7):533-540. doi: 10.2519/jospt.2018.8053. Epub 2018 May 8.

    PubMed 29739302
  • Fino PC, Becker LN, Fino NF, Griesemer B, Goforth M, Brolinson PG. Effects of Recent Concussion and Injury History on Instantaneous Relative Risk of Lower Extremity Injury in Division I Collegiate Athletes. Clin J Sport Med. 2019 May;29(3):218-223. doi: 10.1097/JSM.0000000000000502.

    PubMed 31033615
  • McPherson AL, Nagai T, Webster KE, Hewett TE. Musculoskeletal Injury Risk After Sport-Related Concussion: A Systematic Review and Meta-analysis. Am J Sports Med. 2019 Jun;47(7):1754-1762. doi: 10.1177/0363546518785901. Epub 2018 Aug 3.

    PubMed 30074832
  • Murray DA, Meldrum D, Lennon O. Can vestibular rehabilitation exercises help patients with concussion? A systematic review of efficacy, prescription and progression patterns. Br J Sports Med. 2017 Mar;51(5):442-451. doi: 10.1136/bjsports-2016-096081. Epub 2016 Sep 21.

    PubMed 27655831
  • Carter KM, Pauhl AN, Christie AD. The Role of Active Rehabilitation in Concussion Management: A Systematic Review and Meta-analysis. Med Sci Sports Exerc. 2021 Sep 1;53(9):1835-1845. doi: 10.1249/MSS.0000000000002663.

    PubMed 33787531
  • Reid SA, Farbenblum J, McLeod S. Do physical interventions improve outcomes following concussion: a systematic review and meta-analysis? Br J Sports Med. 2022 Mar;56(5):292-298. doi: 10.1136/bjsports-2020-103470. Epub 2021 Sep 30.

    PubMed 34593371
  • Paul SS, Dibble LE, Walther RG, Shelton C, Gurgel RK, Lester ME. Characterization of Head-Trunk Coordination Deficits After Unilateral Vestibular Hypofunction Using Wearable Sensors. JAMA Otolaryngol Head Neck Surg. 2017 Oct 1;143(10):1008-1014. doi: 10.1001/jamaoto.2017.1443.

    PubMed 28859201

Questions about this trial

What is this clinical trial studying?

A study testing Vestibular therapy for mTBI augmented with audio and visual real-time biofeedback and Vestibular therapy for mTBI in people with Mild Traumatic Brain Injury, Concussion and Rehabilitation, run by Oregon Health and Science University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laurie A King, PhD, PT, MCR (503-418-2602, kingla@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Global Impression of Change (PGIC) (time frame: Week 8 of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06381674, which also lists 102 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.

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