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

NCT ID: NCT06381674

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-13
• Study Completion Date: 2028-09-30

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.

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.

Conditions

Mild Traumatic Brain Injury, Concussion; Rehabilitation; Balance Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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).

Group Type: ACTIVE_COMPARATOR

Vestibular therapy for mTBI

Intervention Type: OTHER

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

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.

Intervention Type: OTHER

Vestibular therapy for mTBI

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

Intervention Type: OTHER

Other Intervention Names

Rehabilitation; Rehabilitation

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Laurie King

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laurie A King, PhD, DPT

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Site Status: RECRUITING

Fort Sam Houston

San Antonio, Texas, United States

Site Status: NOT_YET_RECRUITING

University of Utah

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Laurie A King, PhD, PT, MCR

Role: CONTACT

kingla@ohsu.edu

503-418-2602

Maggie E Stojak, MS

Role: CONTACT

stojak@ohsu.edu

971-420-4351

Facility Contacts

Laurie A King, PhD, PT, MCR

Role: primary

kingla@ohsu.edu

503-418-2602

Maggie E Stojak, MS

Role: backup

stojak@ohsu.edu

971-420-4351

Angela Weston, PhD, PT

Role: primary

Peter Fino, PhD

Role: primary

peter.fino@utah.edu

801-213-1363

Lee Dibble, PhD, PT

Role: backup

lee.dibble@hsc.utah.edu

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 31654620 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23127680 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16887941 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17691031 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29894203 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21200164 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14625331 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29739302 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31033615 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30074832 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27655831 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33787531 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34593371 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28859201 (View on PubMed)

Paul SS, Dibble LE, Walther RG, Shelton C, Gurgel RK, Lester ME. Reduced Purposeful Head Movements During Community Ambulation Following Unilateral Vestibular Loss. Neurorehabil Neural Repair. 2018 Apr-May;32(4-5):309-316. doi: 10.1177/1545968318770271. Epub 2018 Apr 20.

Reference Type: BACKGROUND

PMID: 29676210 (View on PubMed)

Fino PC, Wilhelm J, Parrington L, Stuart S, Chesnutt JC, King LA. Inertial Sensors Reveal Subtle Motor Deficits When Walking With Horizontal Head Turns After Concussion. J Head Trauma Rehabil. 2019 Mar/Apr;34(2):E74-E81. doi: 10.1097/HTR.0000000000000418.

Reference Type: BACKGROUND

PMID: 30045224 (View on PubMed)

Konrad HR, Tomlinson D, Stockwell CW, Norre M, Horak FB, Shepard NT, Herdman SJ. Rehabilitation therapy for patients with disequilibrium and balance disorders. Otolaryngol Head Neck Surg. 1992 Jul;107(1):105-8. doi: 10.1177/019459989210700117.

Reference Type: BACKGROUND

PMID: 1528589 (View on PubMed)

Cabrera Kang CM, Tusa RJ. Vestibular rehabilitation: rationale and indications. Semin Neurol. 2013 Jul;33(3):276-85. doi: 10.1055/s-0033-1354593. Epub 2013 Sep 21.

Reference Type: BACKGROUND

PMID: 24057831 (View on PubMed)

Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Evidence-Based Clinical Practice Guideline: FROM THE AMERICAN PHYSICAL THERAPY ASSOCIATION NEUROLOGY SECTION. J Neurol Phys Ther. 2016 Apr;40(2):124-55. doi: 10.1097/NPT.0000000000000120.

Reference Type: BACKGROUND

PMID: 26913496 (View on PubMed)

Loyd BJ, Saviers-Steiger J, Fangman A, Ballard P, Taylor C, Schubert M, Dibble L. Turning Toward Monitoring of Gaze Stability Exercises: The Utility of Wearable Sensors. J Neurol Phys Ther. 2020 Oct;44(4):261-267. doi: 10.1097/NPT.0000000000000329.

Reference Type: BACKGROUND

PMID: 32815892 (View on PubMed)

Martini DNP, Wilhelm, J.L., Parrington, L., King, L.A. Wearable Sensors for Vestibular Rehabilitation: A Pilot Study. Journal of Physiotherapy Research. 2021; 5(8):31.

Reference Type: BACKGROUND

Winstein CJ. Knowledge of results and motor learning--implications for physical therapy. Phys Ther. 1991 Feb;71(2):140-9. doi: 10.1093/ptj/71.2.140.

Reference Type: BACKGROUND

PMID: 1989009 (View on PubMed)

Zhou Y, Shao W, Wang L. Effects of Feedback on Students' Motor Skill Learning in Physical Education: A Systematic Review. Int J Environ Res Public Health. 2021 Jun 10;18(12):6281. doi: 10.3390/ijerph18126281.

Reference Type: BACKGROUND

PMID: 34200657 (View on PubMed)

Adams JA. A closed-loop theory of motor learning. J Mot Behav. 1971 Jun;3(2):111-49. doi: 10.1080/00222895.1971.10734898.

Reference Type: BACKGROUND

PMID: 15155169 (View on PubMed)

Dozza M, Chiari L, Horak FB. Audio-biofeedback improves balance in patients with bilateral vestibular loss. Arch Phys Med Rehabil. 2005 Jul;86(7):1401-3. doi: 10.1016/j.apmr.2004.12.036.

Reference Type: BACKGROUND

PMID: 16003671 (View on PubMed)

Moore S, Woollacott M. The use of biofeedback devices to improve postural stability. Phys Ther Pract. 1993;2(2):1-19.

Reference Type: BACKGROUND

Bowman T, Gervasoni E, Arienti C, Lazzarini SG, Negrini S, Crea S, Cattaneo D, Carrozza MC. Wearable Devices for Biofeedback Rehabilitation: A Systematic Review and Meta-Analysis to Design Application Rules and Estimate the Effectiveness on Balance and Gait Outcomes in Neurological Diseases. Sensors (Basel). 2021 May 15;21(10):3444. doi: 10.3390/s21103444.

Reference Type: BACKGROUND

PMID: 34063355 (View on PubMed)

Hebert JR, Forster JE, Stearns-Yoder KA, Penzenik ME, Brenner LA. Persistent Symptoms and Objectively Measured Balance Performance Among OEF/OIF Veterans With Remote Mild Traumatic Brain Injury. J Head Trauma Rehabil. 2018 Nov/Dec;33(6):403-411. doi: 10.1097/HTR.0000000000000385.

Reference Type: BACKGROUND

PMID: 29385020 (View on PubMed)

Herdman SJ, Tusa RJ, Blatt P, Suzuki A, Venuto PJ, Roberts D. Computerized dynamic visual acuity test in the assessment of vestibular deficits. Am J Otol. 1998 Nov;19(6):790-6.

Reference Type: BACKGROUND

PMID: 9831156 (View on PubMed)

Quintana C, Heebner NR, Olson AD, Abt JP, Hoch MC. Sport-specific differences in dynamic visual acuity and gaze stabilization in division-I collegiate athletes. J Vestib Res. 2020;30(4):249-257. doi: 10.3233/VES-200710.

Reference Type: BACKGROUND

PMID: 32925127 (View on PubMed)

Collins MW, Kontos AP, Reynolds E, Murawski CD, Fu FH. A comprehensive, targeted approach to the clinical care of athletes following sport-related concussion. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):235-46. doi: 10.1007/s00167-013-2791-6. Epub 2013 Dec 12.

Reference Type: BACKGROUND

PMID: 24337463 (View on PubMed)

Kontos A. Concussion: A clinical profile approach to assessment and treatment. New Ed: American Psychological Association; 2018.

Reference Type: BACKGROUND

Langdon S, Konigs M, Adang EAMC, Goedhart E, Oosterlaan J. Subtypes of Sport-Related Concussion: a Systematic Review and Meta-cluster Analysis. Sports Med. 2020 Oct;50(10):1829-1842. doi: 10.1007/s40279-020-01321-9.

Reference Type: BACKGROUND

PMID: 32720230 (View on PubMed)

Lumba-Brown A, Teramoto M, Bloom OJ, Brody D, Chesnutt J, Clugston JR, Collins M, Gioia G, Kontos A, Lal A, Sills A, Ghajar J. Concussion Guidelines Step 2: Evidence for Subtype Classification. Neurosurgery. 2020 Jan 1;86(1):2-13. doi: 10.1093/neuros/nyz332.

Reference Type: BACKGROUND

PMID: 31432081 (View on PubMed)

Kontos AP, Elbin RJ, Trbovich A, Womble M, Said A, Sumrok VF, French J, Kegel N, Puskar A, Sherry N, Holland C, Collins M. Concussion Clinical Profiles Screening (CP Screen) Tool: Preliminary Evidence to Inform a Multidisciplinary Approach. Neurosurgery. 2020 Aug 1;87(2):348-356. doi: 10.1093/neuros/nyz545.

Reference Type: BACKGROUND

PMID: 31950187 (View on PubMed)

Gioia G. Defining concussion subtype treatment targets: psychometric properties of the concussion symptom subtypes inventory (CSSI). International Child Neurology Association-CNS; San Diego, CA.2020.

Reference Type: BACKGROUND

Lumba-Brown A, Ghajar J, Cornwell J, Bloom OJ, Chesnutt J, Clugston JR, Kolluri R, Leddy JJ, Teramoto M, Gioia G. Representation of concussion subtypes in common postconcussion symptom-rating scales. Concussion. 2019 Nov 1;4(3):CNC65. doi: 10.2217/cnc-2019-0005.

Reference Type: BACKGROUND

PMID: 31827883 (View on PubMed)

Riemann BL, Guskiewicz KM. Effects of mild head injury on postural stability as measured through clinical balance testing. J Athl Train. 2000 Jan;35(1):19-25.

Reference Type: BACKGROUND

PMID: 16558603 (View on PubMed)

Giza CC, Kutcher JS, Ashwal S, Barth J, Getchius TS, Gioia GA, Gronseth GS, Guskiewicz K, Mandel S, Manley G, McKeag DB, Thurman DJ, Zafonte R. Summary of evidence-based guideline update: evaluation and management of concussion in sports [RETIRED]: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2013 Jun 11;80(24):2250-7. doi: 10.1212/WNL.0b013e31828d57dd. Epub 2013 Mar 18.

Reference Type: BACKGROUND

PMID: 23508730 (View on PubMed)

Finnoff JT, Peterson VJ, Hollman JH, Smith J. Intrarater and interrater reliability of the Balance Error Scoring System (BESS). PM R. 2009 Jan;1(1):50-4. doi: 10.1016/j.pmrj.2008.06.002. Epub 2008 Dec 10.

Reference Type: BACKGROUND

PMID: 19627872 (View on PubMed)

King LA, Horak FB, Mancini M, Pierce D, Priest KC, Chesnutt J, Sullivan P, Chapman JC. Instrumenting the balance error scoring system for use with patients reporting persistent balance problems after mild traumatic brain injury. Arch Phys Med Rehabil. 2014 Feb;95(2):353-9. doi: 10.1016/j.apmr.2013.10.015. Epub 2013 Nov 5.

Reference Type: BACKGROUND

PMID: 24200875 (View on PubMed)

Gera G, Chesnutt J, Mancini M, Horak FB, King LA. Inertial Sensor-Based Assessment of Central Sensory Integration for Balance After Mild Traumatic Brain Injury. Mil Med. 2018 Mar 1;183(suppl_1):327-332. doi: 10.1093/milmed/usx162.

Reference Type: BACKGROUND

PMID: 29635623 (View on PubMed)

Hasegawa N, Shah VV, Harker G, Carlson-Kuhta P, Nutt JG, Lapidus JA, Jung SH, Barlow N, King LA, Horak FB, Mancini M. Responsiveness of Objective vs. Clinical Balance Domain Outcomes for Exercise Intervention in Parkinson's Disease. Front Neurol. 2020 Sep 25;11:940. doi: 10.3389/fneur.2020.00940. eCollection 2020.

Reference Type: BACKGROUND

PMID: 33101161 (View on PubMed)

El-Gohary M, Pearson S, McNames J, Mancini M, Horak F, Mellone S, Chiari L. Continuous monitoring of turning in patients with movement disability. Sensors (Basel). 2013 Dec 27;14(1):356-69. doi: 10.3390/s140100356.

Reference Type: BACKGROUND

PMID: 24379043 (View on PubMed)

Mancini M, King L, Salarian A, Holmstrom L, McNames J, Horak FB. Mobility Lab to Assess Balance and Gait with Synchronized Body-worn Sensors. J Bioeng Biomed Sci. 2011 Dec 12;Suppl 1:007. doi: 10.4172/2155-9538.S1-007.

Reference Type: BACKGROUND

PMID: 24955286 (View on PubMed)

Shah VV, McNames J, Mancini M, Carlson-Kuhta P, Spain RI, Nutt JG, El-Gohary M, Curtze C, Horak FB. Quantity and quality of gait and turning in people with multiple sclerosis, Parkinson's disease and matched controls during daily living. J Neurol. 2020 Apr;267(4):1188-1196. doi: 10.1007/s00415-020-09696-5. Epub 2020 Jan 11.

Reference Type: BACKGROUND

PMID: 31927614 (View on PubMed)

Stuart S, Parrington L, Martini DN, Kreter N, Chesnutt JC, Fino PC, King LA. Analysis of Free-Living Mobility in People with Mild Traumatic Brain Injury and Healthy Controls: Quality over Quantity. J Neurotrauma. 2020 Jan 1;37(1):139-145. doi: 10.1089/neu.2019.6450. Epub 2019 Aug 26.

Reference Type: BACKGROUND

PMID: 31354032 (View on PubMed)

Brooke J. SUS: A Quick and Dirty Usability Scale. Usability Evaluation in Industry. 1996. CRC Press

Reference Type: BACKGROUND

Brooke J. SUS: a retrospective. Journal of Usability Studies. 2013;8:29-40. 51.

Reference Type: BACKGROUND

Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.

Reference Type: BACKGROUND

PMID: 20046623 (View on PubMed)

Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004 Jan;27(1):26-35. doi: 10.1016/j.jmpt.2003.11.003.

Reference Type: BACKGROUND

PMID: 14739871 (View on PubMed)

Powell D, Godfrey A, Parrington L, Campbell KR, King LA, Stuart S. Free-living gait does not differentiate chronic mTBI patients compared to healthy controls. J Neuroeng Rehabil. 2022 May 26;19(1):49. doi: 10.1186/s12984-022-01030-6.

Reference Type: BACKGROUND

PMID: 35619112 (View on PubMed)

Centers for Disease Control and Prevention. Report to congress on traumatic brain injury in the United States: epidemiology and rehabilitation. Atlanta, GA: National Center for Injury Prevention and Control; 2014.

Reference Type: BACKGROUND

Assistant Secretary of Defense. Traumatic brain injury: Updated definition and reporting. Washington DC, Department of Defense; 2015.

Reference Type: BACKGROUND

Hoffer ME, Gottshall K, Viirre ES. Vestibular Consequences of mTBI. in: traumatic brain injury: a clinician's guide to diagnosis, management, and rehabilitation. New York: Springer New York; 2012.139-47.

Reference Type: BACKGROUND

Software NS. Power Analysis & Sample Size (PASS) 2019.

Reference Type: BACKGROUND

Quatman-Yates CC, Hunter-Giordano A, Shimamura KK, Landel R, Alsalaheen BA, Hanke TA, McCulloch KL. Physical Therapy Evaluation and Treatment After Concussion/Mild Traumatic Brain Injury. J Orthop Sports Phys Ther. 2020 Apr;50(4):CPG1-CPG73. doi: 10.2519/jospt.2020.0301.

Reference Type: BACKGROUND

PMID: 32241234 (View on PubMed)

Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.

Reference Type: BACKGROUND

PMID: 12221344 (View on PubMed)

Leddy JJ, Kozlowski K, Donnelly JP, Pendergast DR, Epstein LH, Willer B. A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome. Clin J Sport Med. 2010 Jan;20(1):21-7. doi: 10.1097/JSM.0b013e3181c6c22c.

Reference Type: BACKGROUND

PMID: 20051730 (View on PubMed)

Leddy JJ, Willer B. Use of graded exercise testing in concussion and return-to-activity management. Curr Sports Med Rep. 2013 Nov-Dec;12(6):370-6. doi: 10.1249/JSR.0000000000000008.

Reference Type: BACKGROUND

PMID: 24225521 (View on PubMed)

Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012 Jun;9(3):322-9. doi: 10.1177/1740774512438980. Epub 2012 Feb 27.

Reference Type: BACKGROUND

PMID: 22371630 (View on PubMed)

Kontos AP, Deitrick JM, Collins MW, Mucha A. Review of Vestibular and Oculomotor Screening and Concussion Rehabilitation. J Athl Train. 2017 Mar;52(3):256-261. doi: 10.4085/1062-6050-51.11.05.

Reference Type: BACKGROUND

PMID: 28387548 (View on PubMed)

Wilde EA, Whiteneck GG, Bogner J, Bushnik T, Cifu DX, Dikmen S, French L, Giacino JT, Hart T, Malec JF, Millis SR, Novack TA, Sherer M, Tulsky DS, Vanderploeg RD, von Steinbuechel N. Recommendations for the use of common outcome measures in traumatic brain injury research. Arch Phys Med Rehabil. 2010 Nov;91(11):1650-1660.e17. doi: 10.1016/j.apmr.2010.06.033.

Reference Type: BACKGROUND

PMID: 21044708 (View on PubMed)

Broglio SP, Kontos AP, Levin H, Schneider K, Wilde EA, Cantu RC, Feddermann-Demont N, Fuller GW, Gagnon I, Gioia GA, Giza C, Griesbach GS, Leddy JJ, Lipton ML, Mayer AR, McAllister TW, McCrea M, McKenzie LB, Putukian M, Signoretti S, Suskauer SJ, Tamburro R, Turner M, Yeates KO, Zemek R, Ala'i S, Esterlitz J, Gay K, Bellgowan PSF, Joseph K. National Institute of Neurological Disorders and Stroke and Department of Defense Sport-Related Concussion Common Data Elements Version 1.0 Recommendations. J Neurotrauma. 2018 Dec 1;35(23):2776-2783. doi: 10.1089/neu.2018.5643. Epub 2018 Jul 23.

Reference Type: BACKGROUND

PMID: 29717643 (View on PubMed)

Morris R, Stuart S, McBarron G, Fino PC, Mancini M, Curtze C. Validity of Mobility Lab (version 2) for gait assessment in young adults, older adults and Parkinson's disease. Physiol Meas. 2019 Sep 30;40(9):095003. doi: 10.1088/1361-6579/ab4023.

Reference Type: BACKGROUND

PMID: 31470423 (View on PubMed)

Tate DF, Dennis EL, Adams JT, Adamson MM, Belanger HG, Bigler ED, Bouchard HC, Clark AL, Delano-Wood LM, Disner SG, Eapen BC, Franz CE, Geuze E, Goodrich-Hunsaker NJ, Han K, Hayes JP, Hinds SR 2nd, Hodges CB, Hovenden ES, Irimia A, Kenney K, Koerte IK, Kremen WS, Levin HS, Lindsey HM, Morey RA, Newsome MR, Ollinger J, Pugh MJ, Scheibel RS, Shenton ME, Sullivan DR, Taylor BA, Troyanskaya M, Velez C, Wade BS, Wang X, Ware AL, Zafonte R, Thompson PM, Wilde EA. Coordinating Global Multi-Site Studies of Military-Relevant Traumatic Brain Injury: Opportunities, Challenges, and Harmonization Guidelines. Brain Imaging Behav. 2021 Apr;15(2):585-613. doi: 10.1007/s11682-020-00423-2. Epub 2021 Jan 7.

Reference Type: BACKGROUND

PMID: 33409819 (View on PubMed)

Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011.

Reference Type: BACKGROUND

PMID: 2317323 (View on PubMed)

Gottshall K, Drake A, Gray N, McDonald E, Hoffer ME. Objective vestibular tests as outcome measures in head injury patients. Laryngoscope. 2003 Oct;113(10):1746-50. doi: 10.1097/00005537-200310000-00016.

Reference Type: BACKGROUND

PMID: 14520100 (View on PubMed)

Kaufman KR, Brey RH, Chou LS, Rabatin A, Brown AW, Basford JR. Comparison of subjective and objective measurements of balance disorders following traumatic brain injury. Med Eng Phys. 2006 Apr;28(3):234-9. doi: 10.1016/j.medengphy.2005.05.005. Epub 2005 Jul 25.

Reference Type: BACKGROUND

PMID: 16043377 (View on PubMed)

Basford JR, Chou LS, Kaufman KR, Brey RH, Walker A, Malec JF, Moessner AM, Brown AW. An assessment of gait and balance deficits after traumatic brain injury. Arch Phys Med Rehabil. 2003 Mar;84(3):343-9. doi: 10.1053/apmr.2003.50034.

Reference Type: BACKGROUND

PMID: 12638101 (View on PubMed)

Lin LF, Liou TH, Hu CJ, Ma HP, Ou JC, Chiang YH, Chiu WT, Tsai SH, Chu WC. Balance function and sensory integration after mild traumatic brain injury. Brain Inj. 2015;29(1):41-6. doi: 10.3109/02699052.2014.955881.

Reference Type: BACKGROUND

PMID: 25265292 (View on PubMed)

King PR, Donnelly KT, Donnelly JP, Dunnam M, Warner G, Kittleson CJ, Bradshaw CB, Alt M, Meier ST. Psychometric study of the Neurobehavioral Symptom Inventory. J Rehabil Res Dev. 2012;49(6):879-88. doi: 10.1682/jrrd.2011.03.0051.

Reference Type: BACKGROUND

PMID: 23299259 (View on PubMed)

von Steinbuchel N, Wilson L, Gibbons H, Hawthorne G, Hofer S, Schmidt S, Bullinger M, Maas A, Neugebauer E, Powell J, von Wild K, Zitnay G, Bakx W, Christensen AL, Koskinen S, Formisano R, Saarajuri J, Sasse N, Truelle JL; QOLIBRI Task Force. Quality of Life after Brain Injury (QOLIBRI): scale validity and correlates of quality of life. J Neurotrauma. 2010 Jul;27(7):1157-65. doi: 10.1089/neu.2009.1077.

Reference Type: BACKGROUND

PMID: 20210602 (View on PubMed)

Moore BM, Adams JT, Barakatt E. Outcomes Following a Vestibular Rehabilitation and Aerobic Training Program to Address Persistent Post-Concussion Symptoms. J Allied Health. 2016 Winter;45(4):e59-e68.

Reference Type: BACKGROUND

PMID: 27915363 (View on PubMed)

van der Naalt J, van Zomeren AH, Sluiter WJ, Minderhoud JM. One year outcome in mild to moderate head injury: the predictive value of acute injury characteristics related to complaints and return to work. J Neurol Neurosurg Psychiatry. 1999 Feb;66(2):207-13. doi: 10.1136/jnnp.66.2.207.

Reference Type: BACKGROUND

PMID: 10071101 (View on PubMed)

Shumway-Cook A, Horak FB. Assessing the influence of sensory interaction of balance. Suggestion from the field. Phys Ther. 1986 Oct;66(10):1548-50. doi: 10.1093/ptj/66.10.1548. No abstract available.

Reference Type: BACKGROUND

PMID: 3763708 (View on PubMed)

Pape MM, Kodosky PN, Hoover P. The Community Balance and Mobility Scale: Detecting Impairments in Military Service Members With Mild Traumatic Brain Injury. Mil Med. 2020 Mar 2;185(3-4):428-435. doi: 10.1093/milmed/usz265.

Reference Type: BACKGROUND

PMID: 31621858 (View on PubMed)

Pin TW. Psychometric properties of 2-minute walk test: a systematic review. Arch Phys Med Rehabil. 2014 Sep;95(9):1759-75. doi: 10.1016/j.apmr.2014.03.034. Epub 2014 May 9.

Reference Type: BACKGROUND

PMID: 24814460 (View on PubMed)

Fino PC, Weightman MM, Dibble LE, Lester ME, Hoppes CW, Parrington L, Arango J, Souvignier A, Roberts H, King LA. Objective Dual-Task Turning Measures for Return-to-Duty Assessment After Mild Traumatic Brain Injury: The ReTURN Study Protocol. Front Neurol. 2021 Jan 15;11:544812. doi: 10.3389/fneur.2020.544812. eCollection 2020.

Reference Type: BACKGROUND

PMID: 33519659 (View on PubMed)

Mucha A, Collins MW, Elbin RJ, Furman JM, Troutman-Enseki C, DeWolf RM, Marchetti G, Kontos AP. A Brief Vestibular/Ocular Motor Screening (VOMS) assessment to evaluate concussions: preliminary findings. Am J Sports Med. 2014 Oct;42(10):2479-86. doi: 10.1177/0363546514543775. Epub 2014 Aug 8.

Reference Type: BACKGROUND

PMID: 25106780 (View on PubMed)

Badke MB, Shea TA, Miedaner JA, Grove CR. Outcomes after rehabilitation for adults with balance dysfunction. Arch Phys Med Rehabil. 2004 Feb;85(2):227-33. doi: 10.1016/j.apmr.2003.06.006.

Reference Type: BACKGROUND

PMID: 14966706 (View on PubMed)

Dannenbaum E, Paquet N, Chilingaryan G, Fung J. Clinical evaluation of dynamic visual acuity in subjects with unilateral vestibular hypofunction. Otol Neurotol. 2009 Apr;30(3):368-72. doi: 10.1097/MAO.0b013e31819bda35.

Reference Type: BACKGROUND

PMID: 19318888 (View on PubMed)

Washabaugh EP, Kalyanaraman T, Adamczyk PG, Claflin ES, Krishnan C. Validity and repeatability of inertial measurement units for measuring gait parameters. Gait Posture. 2017 Jun;55:87-93. doi: 10.1016/j.gaitpost.2017.04.013. Epub 2017 Apr 12.

Reference Type: BACKGROUND

PMID: 28433867 (View on PubMed)

King LA, Mancini M, Fino PC, Chesnutt J, Swanson CW, Markwardt S, Chapman JC. Sensor-Based Balance Measures Outperform Modified Balance Error Scoring System in Identifying Acute Concussion. Ann Biomed Eng. 2017 Sep;45(9):2135-2145. doi: 10.1007/s10439-017-1856-y. Epub 2017 May 24.

Reference Type: BACKGROUND

PMID: 28540448 (View on PubMed)

Parrington L, King LA, Weightman MM, Hoppes CW, Lester ME, Dibble LE, Fino PC. Between-site equivalence of turning speed assessments using inertial measurement units. Gait Posture. 2021 Oct;90:245-251. doi: 10.1016/j.gaitpost.2021.09.164. Epub 2021 Sep 9.

Reference Type: BACKGROUND

PMID: 34530311 (View on PubMed)

Loyd BJ, Dibble LE, Weightman MM, Pelo R, Hoppes CW, Lester M, King LA, Fino PC. Volitional Head Movement Deficits and Alterations in Gait Speed Following Mild Traumatic Brain Injury. J Head Trauma Rehabil. 2023 May-Jun 01;38(3):E223-E232. doi: 10.1097/HTR.0000000000000831. Epub 2022 Oct 14.

Reference Type: BACKGROUND

PMID: 36731009 (View on PubMed)

Stuart S, Parrington L, Morris R, Martini DN, Fino PC, King LA. Gait measurement in chronic mild traumatic brain injury: A model approach. Hum Mov Sci. 2020 Feb;69:102557. doi: 10.1016/j.humov.2019.102557. Epub 2019 Nov 26.

Reference Type: BACKGROUND

PMID: 31783306 (View on PubMed)

Fino PC, Parrington L, Walls M, Sippel E, Hullar TE, Chesnutt JC, King LA. Abnormal Turning and Its Association with Self-Reported Symptoms in Chronic Mild Traumatic Brain Injury. J Neurotrauma. 2018 May 15;35(10):1167-1177. doi: 10.1089/neu.2017.5231. Epub 2018 Mar 23.

Reference Type: BACKGROUND

PMID: 29078732 (View on PubMed)

Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA. Psychometric properties of the PTSD Checklist (PCL). Behav Res Ther. 1996 Aug;34(8):669-73. doi: 10.1016/0005-7967(96)00033-2.

Reference Type: BACKGROUND

PMID: 8870294 (View on PubMed)

Ruggiero KJ, Del Ben K, Scotti JR, Rabalais AE. Psychometric properties of the PTSD Checklist-Civilian Version. J Trauma Stress. 2003 Oct;16(5):495-502. doi: 10.1023/A:1025714729117.

Reference Type: BACKGROUND

PMID: 14584634 (View on PubMed)

Kontos AP, Sufrinko A, Sandel N, Emami K, Collins MW. Sport-related Concussion Clinical Profiles: Clinical Characteristics, Targeted Treatments, and Preliminary Evidence. Curr Sports Med Rep. 2019 Mar;18(3):82-92. doi: 10.1249/JSR.0000000000000573.

Reference Type: BACKGROUND

PMID: 30855306 (View on PubMed)

Chan F, Gelman JS, Ditchman N, Kim J-H, Chiu C-Y. The World Health Organization ICF model as a conceptual framework of disability. Understanding psychosocial adjustment to chronic illness and disability: A handbook for evidence-based practitioners in rehabilitation. New York, NY, US: Springer Publishing Company; 2009. p. 23-50.

Reference Type: BACKGROUND

Houston MN, Bay RC, Valovich McLeod TC. The relationship between post-injury measures of cognition, balance, symptom reports and health-related quality-of-life in adolescent athletes with concussion. Brain Inj. 2016;30(7):891-8. doi: 10.3109/02699052.2016.1146960. Epub 2016 Apr 18.

Reference Type: BACKGROUND

PMID: 27088297 (View on PubMed)

van Ierssel J, Sveistrup H, Marshall S. Identifying the concepts contained within health-related quality of life outcome measures in concussion research using the International Classification of Functioning, Disability, and Health as a reference: a systematic review. Qual Life Res. 2018 Dec;27(12):3071-3086. doi: 10.1007/s11136-018-1939-8. Epub 2018 Jul 20.

Reference Type: BACKGROUND

PMID: 30030674 (View on PubMed)

Aandstad A, Hageberg R, Holme IM, Anderssen SA. Objectively Measured Physical Activity in Home Guard Soldiers During Military Service and Civilian Life. Mil Med. 2016 Jul;181(7):693-700. doi: 10.7205/MILMED-D-15-00147.

Reference Type: BACKGROUND

PMID: 27391624 (View on PubMed)

Wynd CA, Bonnefil C, Harris JS. A comparison of health needs and personal health goals of Army Reserve Military and civilian employees. Mil Med. 2001 Jan;166(1):14-20.

Reference Type: BACKGROUND

PMID: 11197090 (View on PubMed)

Wynd CA, Ryan-Wenger NA. Factors predicting health behaviors among Army Reserve, active duty Army, and civilian hospital employees. Mil Med. 2004 Dec;169(12):942-7. doi: 10.7205/milmed.169.12.942.

Reference Type: BACKGROUND

PMID: 15646182 (View on PubMed)

Ballweg JA, Li L. Comparison of health habits of military personnel with civilian populations. Public Health Rep. 1989 Sep-Oct;104(5):498-509.

Reference Type: BACKGROUND

PMID: 2508180 (View on PubMed)

van Poppel MN, Chinapaw MJ, Mokkink LB, van Mechelen W, Terwee CB. Physical activity questionnaires for adults: a systematic review of measurement properties. Sports Med. 2010 Jul 1;40(7):565-600. doi: 10.2165/11531930-000000000-00000.

Reference Type: BACKGROUND

PMID: 20545381 (View on PubMed)

Peel C, Sawyer Baker P, Roth DL, Brown CJ, Brodner EV, Allman RM. Assessing mobility in older adults: the UAB Study of Aging Life-Space Assessment. Phys Ther. 2005 Oct;85(10):1008-119.

Reference Type: BACKGROUND

PMID: 16180950 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study Protocol and Statistical Analysis Plan

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Document Type: Statistical Analysis Plan: Updated Statistical Analysis Document

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Other Identifiers

HT9425-23-1-0845

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

OHSU: 25890

Identifier Type: -

Identifier Source: org_study_id