Clinical trial NCT06381674: Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation
Official title: Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury, Concussion
Rehabilitation
Balance Impairment
Keywords: mild traumatic brain injury (mTBI)
concussion
vestibular
ocular
balance
rehabilitation
biofeedback
wearable sensors
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two groups in this study that will be randomized concurrently into two different rehabilitation programs.
Primary purpose: TREATMENT

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.

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 requiring a profile) 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).

Primary outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 8 of study
Secondary outcomes:
measure: Concussion Clinical Profiles Screening (CP Screening)
timeFrame: Weeks 1 and 8 of study
measure: Dizziness Handicap Index (DHI)
timeFrame: Weeks 1 and 8 of study
measure: Quality of Life After Brain Injury (QOLIBRI)
timeFrame: Weeks 1 and 8 of study
measure: The Patient Reported Outcomes Measurement Information System (PROMIS)-Satisfaction with Participation in Social Roles-Short Form 4a
timeFrame: Weeks 1 and 8 of study
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Weeks 1 and 8 of study
measure: Headache Impact Test (HIT-6)
timeFrame: Weeks 1 and 8 of study
measure: Insomnia Severity Index (ISI)
timeFrame: Weeks 1 and 8 of study
measure: Neck Disability Index (NDI)
timeFrame: Weeks 1 and 8 of study
measure: Convergence Insufficiency Symptom Survey (CISS)
timeFrame: Weeks 1 and 8 of study
measure: Vertigo Symptom Scale (VSS)
timeFrame: Weeks 1 and 8 of study
measure: Automated Neuropsychological Assessment Metric (ANAM)
timeFrame: Weeks 1 and 8 of study
measure: Dynamic Visual Acuity ( DVA-Clinical)
timeFrame: Weeks 1 and 8 of study
measure: Ocular Motor Function Tests
timeFrame: Weeks 1 and 8 of study
measure: Video Head Impulse Test (vHIT)
timeFrame: Weeks 1 and 8 of study
measure: Functional Gait Assessment (FGA)
timeFrame: Weeks 1 and 8 of study
measure: Complex Turning Course (CTC)
timeFrame: Weeks 1 and 8 of study
measure: Modified Balance Error Scoring System (mBESS)
timeFrame: Weeks 1 and 8 of study
measure: Modified Clinical Test for Sensory Integration on Balance (mCTSIB)
timeFrame: Weeks 1 and 8 of study
measure: Instrumented One Minute Walk (Single and Dual Task)
timeFrame: Weeks 1 and 8 of study
measure: Hybrid Assessment of Mobility (HAM-4)
timeFrame: Weeks 1 and 8 of study
measure: Tandem Gait (Single and Dual Task)
timeFrame: Weeks 1 and 8 of study
measure: Vestibular Ocular Motor Screening (VOMS)
timeFrame: Weeks 1 and 8 of study
measure: Central Sensorimotor Integration Testing (CSMI)
timeFrame: Weeks 1 and 8 of study
measure: Reactive Balance
timeFrame: Weeks 1 and 8 of study
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: San Antonio
country: United States
facility: Fort Sam Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Oregon Health and Science University
name: Laurie A King, PhD, DPT
role: PRINCIPAL_INVESTIGATOR
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