Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation
- Conditions
- Mild Traumatic Brain Injury, ConcussionRehabilitationBalance Impairment
- Interventions
- Other: Vestibular therapy for mTBI augmented with audio and visual real-time biofeedbackOther: Vestibular therapy for mTBI
- Registration Number
- NCT06381674
- Lead Sponsor
- Oregon Health and Science University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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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.
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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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vestibular Therapy Augmented with Audio and Visual Real-Time Biofeedback Vestibular therapy for mTBI 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. Vestibular Therapy-Standard of Care Vestibular therapy for mTBI This arm will receive 12 sessions of vestibular physical therapy over 6-weeks based on clinical practice guidelines for mTBI (concussion).
- Primary Outcome Measures
Name Time Method Patient Global Impression of Change (PGIC) 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.
- Secondary Outcome Measures
Name Time Method Concussion Clinical Profiles Screening (CP Screening) Weeks 1 and 8 of study 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.
Dizziness Handicap Index (DHI) Weeks 1 and 8 of study 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.
Quality of Life After Brain Injury (QOLIBRI) Weeks 1 and 8 of study 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).
The Patient Reported Outcomes Measurement Information System (PROMIS)-Satisfaction with Participation in Social Roles-Short Form 4a Weeks 1 and 8 of study 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.
Hospital Anxiety and Depression Scale (HADS) Weeks 1 and 8 of study 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).
Headache Impact Test (HIT-6) Weeks 1 and 8 of study 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.
Dynamic Visual Acuity ( DVA-Clinical) Weeks 1 and 8 of study 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.
Insomnia Severity Index (ISI) Weeks 1 and 8 of study 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).
Neck Disability Index (NDI) Weeks 1 and 8 of study 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%).
Convergence Insufficiency Symptom Survey (CISS) Weeks 1 and 8 of study 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.
Vertigo Symptom Scale (VSS) Weeks 1 and 8 of study 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: 0-60Automated Neuropsychological Assessment Metric (ANAM) Weeks 1 and 8 of study This is a computerized neurocognitive test that takes about 20 minutes to complete. The ANAM collects information on attention, memory, or thinking ability.
Ocular Motor Function Tests Weeks 1 and 8 of study These tests will ask the participant to move their eyes in various directions.
Video Head Impulse Test (vHIT) Weeks 1 and 8 of study This test will have the participant looking at a stationary object while their head is moved quickly.
Functional Gait Assessment (FGA) Weeks 1 and 8 of study 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.
Complex Turning Course (CTC) Weeks 1 and 8 of study This is a test of mobility that evaluates a person's ability to walk a prescribed path involving multiple turns of various angles.
Modified Balance Error Scoring System (mBESS) Weeks 1 and 8 of study 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.
Modified Clinical Test for Sensory Integration on Balance (mCTSIB) Weeks 1 and 8 of study 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.
Instrumented One Minute Walk (Single and Dual Task) Weeks 1 and 8 of study This is a measurement of over-ground walking performance over 1 minute with and without additional cognitive tasks.
Hybrid Assessment of Mobility (HAM-4) Weeks 1 and 8 of study 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.
Tandem Gait (Single and Dual Task) Weeks 1 and 8 of study 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.
Vestibular Ocular Motor Screening (VOMS) Weeks 1 and 8 of study 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.
Central Sensorimotor Integration Testing (CSMI) Weeks 1 and 8 of study 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.
Reactive Balance Weeks 1 and 8 of study The participant will be tested on their reactive stepping in the anterior, posterior, and lateral directions.
Trial Locations
- Locations (3)
University of Utah
🇺🇸Salt Lake City, Utah, United States
Fort Sam Houston
🇺🇸San Antonio, Texas, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States