Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation (SuBTyPE)
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About
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.
Full 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.
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Inclusion criteria
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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
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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 requiring a profile) 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).
Trial design
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100 participants in 2 patient groups
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Central trial contact
Laurie A King, PhD, PT, MCR; Maggie E Stojak, MS
Data sourced from clinicaltrials.gov
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