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.
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
- Conditions the study is for
- Mild Traumatic Brain Injury, Concussion, Rehabilitation, Balance Impairment
- 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.
United States3 sites, 3 recruiting
- 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
- Not yet recruiting
Fort Sam Houston
San Antonio, Texas, 78234
Angela Weston, PhD, PT
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:
- 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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Vestibular therapy for mTBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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
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
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
Ocular Motor Function Tests
These tests will ask the participant to move their eyes in various directions.
Measured: Weeks 1 and 8 of study
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
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
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
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
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
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
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
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
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
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
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
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.
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.
- First posted24 Apr 2024
- Study start13 Jun 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (102)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain Injury, ConcussionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Laurie King, Oregon Health and Science University
- Investigators
- Laurie A King, PhD, DPT, Principal investigator, Oregon Health and Science University
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 31654620Coronado 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 23127680Corso 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 16887941Vanderploeg 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 17691031Walker 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 29894203McCrory 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 21200164Guskiewicz 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 14625331Kardouni 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 29739302Fino 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 31033615McPherson 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 30074832Murray 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 27655831Carter 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 33787531Reid 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 34593371Paul 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation
- ClinicalTrials.gov ID
- NCT06381674
- Acronym / sponsor ID
- SuBTyPE / OHSU: 25890
- Keywords
- mild traumatic brain injury (mTBI), concussion, vestibular, ocular, balance, rehabilitation, biofeedback, wearable sensors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There will be two groups in this study that will be randomized concurrently into two different rehabilitation programs.
| Arm | Type | Receives |
|---|---|---|
| Vestibular Therapy Augmented with Audio and Visual Real-Time Biofeedback | Experimental | Other: Vestibular therapy for mTBI augmented with audio and visual real-time biofeedbackThis 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. |
| Vestibular Therapy-Standard of Care | Active comparator | Other: Vestibular therapy for mTBIThis arm will receive 12 sessions of vestibular physical therapy over 6-weeks based on clinical practice guidelines for mTBI (concussion). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- For all Aims, participants may be either civilians, active duty military, or Veterans, and must:
Key exclusion criteria (12 listed)
- Participants must not:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular therapy for mTBI augmented with audio and visual real-time biofeedbackAlso: RehabilitationDuring 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. | Other | Vestibular Therapy Augmented with Audio and Visual Real-Time Biofeedback |
| Vestibular therapy for mTBIAlso: RehabilitationDuring physical therapy sessions participants will go through vestibular therapeutic exercise WITHOUT audio and visual real-time biofeedback. | Other | Vestibular Therapy-Standard of Care |
Primary outcome
Patient Global Impression of Change (PGIC)
Time frame: Week 8 of study
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.
26 secondary outcomes
Concussion Clinical Profiles Screening (CP Screening)
Time frame: Weeks 1 and 8 of study
Dizziness Handicap Index (DHI)
Time frame: Weeks 1 and 8 of study
Quality of Life After Brain Injury (QOLIBRI)
Time frame: Weeks 1 and 8 of study
The Patient Reported Outcomes Measurement Information System (PROMIS)-Satisfaction with Participation in Social Roles-Short Form 4a
Time frame: Weeks 1 and 8 of study
Hospital Anxiety and Depression Scale (HADS)
Time frame: Weeks 1 and 8 of study
Headache Impact Test (HIT-6)
Time frame: Weeks 1 and 8 of study
Insomnia Severity Index (ISI)
Time frame: Weeks 1 and 8 of study
Neck Disability Index (NDI)
Time frame: Weeks 1 and 8 of study
Convergence Insufficiency Symptom Survey (CISS)
Time frame: Weeks 1 and 8 of study
Vertigo Symptom Scale (VSS)
Time frame: Weeks 1 and 8 of study
Automated Neuropsychological Assessment Metric (ANAM)
Time frame: Weeks 1 and 8 of study
Dynamic Visual Acuity ( DVA-Clinical)
Time frame: Weeks 1 and 8 of study
Ocular Motor Function Tests
Time frame: Weeks 1 and 8 of study
Video Head Impulse Test (vHIT)
Time frame: Weeks 1 and 8 of study
Functional Gait Assessment (FGA)
Time frame: Weeks 1 and 8 of study
Complex Turning Course (CTC)
Time frame: Weeks 1 and 8 of study
Modified Balance Error Scoring System (mBESS)
Time frame: Weeks 1 and 8 of study
Modified Clinical Test for Sensory Integration on Balance (mCTSIB)
Time frame: Weeks 1 and 8 of study
Instrumented One Minute Walk (Single and Dual Task)
Time frame: Weeks 1 and 8 of study
Hybrid Assessment of Mobility (HAM-4)
Time frame: Weeks 1 and 8 of study
Tandem Gait (Single and Dual Task)
Time frame: Weeks 1 and 8 of study
Vestibular Ocular Motor Screening (VOMS)
Time frame: Weeks 1 and 8 of study
Central Sensorimotor Integration Testing (CSMI)
Time frame: Weeks 1 and 8 of study
Reactive Balance
Time frame: Weeks 1 and 8 of study
Neurobehavioral Symptoms Inventory (NSI)
Time frame: Weeks 1 and 8 of the study.
International Physical Activity Questionnaire (IPAQ)
Time frame: Weeks 1 and 8 of study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- BackgroundThe 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.
- Background: PubMed 31654620Silverberg 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.
- Background: PubMed 23127680Coronado 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.
- Background: PubMed 16887941Corso 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.
- Background: PubMed 17691031Vanderploeg 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.
- Background: PubMed 29894203Walker 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.
- Background: PubMed 21200164McCrory 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.
- Background: PubMed 14625331Guskiewicz 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.
- Background: PubMed 29739302Kardouni 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.
- Background: PubMed 31033615Fino 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.
- Background: PubMed 30074832McPherson 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.
- Background: PubMed 27655831Murray 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.
Related trials for Mild Traumatic Brain Injury, Concussion
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
Enrolling by invitation
Risk Assessment of Mild Traumatic Brain Injury in Military Training
Trauma, Brain
Not yet recruiting
Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
Concussion (Diagnosis), Gait Abnormality
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurie A King, PhD, DPT principal investigator
Oregon Health and Science University
3 sites in 1 country: see every site and its status.
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.