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

Rehabilitation Clinical Trial

— SuBTyPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381674
• Other study ID #: OHSU: 25890
• Secondary ID: HT9425-23-1-0845
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2024
• Est. completion date: September 30, 2028

Study information

• Verified date: June 2024
• Source: Oregon Health and Science University
• Contact: Laurie A King, PhD, DPT
• Phone: 503-418-2602
• Email: kingla[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2028
• Est. primary completion date: September 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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 18-50 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., stroke, a more severe brain injury, recent lower extremity or spine orthopedic injury or surgery)

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 validity of data collection or safety during 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 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

Related Conditions & MeSH terms

• Balance Impairment
• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury, Concussion
• Rehabilitation

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon
United States	University of Utah	Salt Lake City	Utah
United States	Fort Sam Houston	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	United States Department of Defense

Country where clinical trial is conducted

United States, 

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* Note: There are 101 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Global Impression of Change (PGIC)	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.	Week 8 of study
Secondary	Concussion Clinical Profiles Screening (CP Screening)	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.	Weeks 1 and 8 of study
Secondary	Dizziness Handicap Index (DHI)	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.	Weeks 1 and 8 of study
Secondary	Quality of Life After Brain Injury (QOLIBRI)	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).	Weeks 1 and 8 of study
Secondary	The Patient Reported Outcomes Measurement Information System (PROMIS)-Satisfaction with Participation in Social Roles-Short Form 4a	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.	Weeks 1 and 8 of study
Secondary	Hospital Anxiety and Depression Scale (HADS)	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).	Weeks 1 and 8 of study
Secondary	Headache Impact Test (HIT-6)	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.	Weeks 1 and 8 of study
Secondary	Insomnia Severity Index (ISI)	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).	Weeks 1 and 8 of study
Secondary	Neck Disability Index (NDI)	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%).	Weeks 1 and 8 of study
Secondary	Convergence Insufficiency Symptom Survey (CISS)	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.	Weeks 1 and 8 of study
Secondary	Vertigo Symptom Scale (VSS)	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: 0-60	Weeks 1 and 8 of study
Secondary	Concussion Symptom Subtypes Inventory (CSSI)	This questionnaire has 41 questions related to the subtypes of concussion. Participants will assess their symptoms at two points in time - now (Current Symptoms Yesterday/Today) and before the concussion (Before Injury/Pre-Injury). Symptoms will be rated at these two points in time. Choose the number to tell us how much you are having this symptom. Choosing "0" means the participant does not have the symptom. Choosing the additional numbers indicates an increasing severity of the symptom, with "6" being the most severe.	Weeks 1 and 8 of study
Secondary	Automated Neuropsychological Assessment Metric (ANAM)	This is a computerized neurocognitive test that takes about 20 minutes to complete. The ANAM collects information on attention, memory, or thinking ability.	Weeks 1 and 8 of study
Secondary	Dynamic Visual Acuity ( DVA-Clinical)	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.	Weeks 1 and 8 of study
Secondary	Ocular Motor Function Tests	These tests will ask the participant to move their eyes in various directions.	Weeks 1 and 8 of study
Secondary	Video Head Impulse Test (vHIT)	This test will have the participant looking at a stationary object while their head is moved quickly.	Weeks 1 and 8 of study
Secondary	Functional Gait Assessment (FGA)	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.	Weeks 1 and 8 of study
Secondary	Complex Turning Course (CTC)	This is a test of mobility that evaluates a person's ability to walk a prescribed path involving multiple turns of various angles.	Weeks 1 and 8 of study
Secondary	Modified Balance Error Scoring System (mBESS)	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.	Weeks 1 and 8 of study
Secondary	Modified Clinical Test for Sensory Integration on Balance (mCTSIB)	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.	Weeks 1 and 8 of study
Secondary	Instrumented One Minute Walk (Single and Dual Task)	This is a measurement of over-ground walking performance over 1 minute with and without additional cognitive tasks.	Weeks 1 and 8 of study
Secondary	Hybrid Assessment of Mobility (HAM-4)	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.	Weeks 1 and 8 of study
Secondary	Tandem Gait (Single and Dual Task)	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.	Weeks 1 and 8 of study
Secondary	Vestibular Ocular Motor Screening (VOMS)	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.	Weeks 1 and 8 of study
Secondary	Central Sensorimotor Integration Testing (CSMI)	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.	Weeks 1 and 8 of study