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

Overview

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• Participants must not:

• have had or currently have any other injury, medical, or neurological illness that could potentially explain balance or vision deficits (e.g., CNS disease, stroke, epilepsy, greater than mild TBI, Meniere's, bilateral vestibular loss, recent lower extremity or spine orthopedic injury that impairs mobility) this includes unresolved symptoms from previous concussions
• meet criteria for moderate to severe substance-use disorder within the past month, as defined by DSM-V
• display behavior that would significantly interfere with the validity of data collection or safety during the study
• be in significant pain during the evaluation (> 7/10 by patient subjective report)
• be a pregnant female (balance considerations)
• been hospitalized for any brain injuries (separate from the emergency department)
• have significant joint pain or recent musculoskeletal injury that limits walking or mobility
• have had any major surgeries in the past year or amputation
• use an assistive device
• unable to stand barefoot
• currently receiving rehabilitation services for their mTBI or injuries related to their concussion (if rehabilitation has been completed more than 1 month ago participants may still be included).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 3 centers

• Oregon Health & Science University — Portland
• Fort Sam Houston — San Antonio
• University of Utah — Salt Lake City

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. Epu PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 14625331

Identifiers

NCT: NCT06381674 · OHSU: 25890 · HT9425-23-1-0845

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗