Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes in mTBI?

Oregon Health and Science University203 enrolled

Overview

Every year 1.7 million people sustain a traumatic brain injury (TBI) in the United States and of these, 84 % are considered mild TBI (mTBI). mTBI is common both in civilian and military populations and can be debilitating if symptoms do not resolve after injury. Balance problems are one of the most common complaints after sustaining a mTBI and often prevent individuals from returning to their previous quality of life. However, the investigators currently lack clear guidelines on when to initiate physical therapy rehabilitation and it is unclear if early physical therapy is beneficial. The investigators believe that the underlying problem of imbalance results from damage to parts of the brain responsible for interpreting sensory information for balance control. The investigators hypothesize that retraining the brain early, as opposed to months after injury, to correctly interpret sensory information will improve recovery. The investigators also believe this retraining is limited when rehabilitation exercises are performed incorrectly, and that performance feedback from wearable sensors, can improve balance rehabilitation. There are three objectives of this study: 1) to determine how the timing of rehabilitation affects outcomes after mTBI; 2) to determine if home monitoring of balance exercises using wearable sensors improves outcomes; and 3) to develop a novel feedback system using wearable sensors to provide the physical therapist information, in real-time during training, about quality of head and trunk movements during prescribed exercises. The findings from this research could be very readily adopted into military protocols for post-mTBI care and have the potential to produce better balance rehabilitation and quality of life for mTBI patients and their families.

Although balance is one of the most common and debilitating complaints after mTBI, the investigators currently lack clear guidelines on when to initiate balance rehabilitation and it is unclear if early physical therapy is beneficial. There is a clear gap in clinical care guidelines after mTBI and it is unclear if initiating rehabilitation early would improve outcomes related to imbalance. Measures of imbalance are subjective and are easily overlooked as a treatable deficit. Even with rehabilitation, recovery of balance in people with mTBI is challenging, particularly in people with central vestibular and sensory integration deficits. Although vestibular and balance rehabilitation after mTBI relies heavily on a home exercise program and repetition is essential for recovery; The slow progress in balance rehabilitation may be partially due to an inability of people with mTBI to correctly perform the prescribed rehabilitation exercises on their own. Biofeedback is a clinical technique that provides physiologic information that would otherwise be unknown to patients and may improve outcomes after mTBI. There are no commercially available systems to provide the physical therapist and/or patient objective information on the quality of head movements during training of rehabilitation tasks that involve balance and walking. Therefore, the three objectives of this study are: 1) to determine how the timing of rehabilitation affects outcomes after mTBI; 2) to determine if home monitoring of home balance exercises using wearable sensors improves outcomes; and 3) to develop a novel feedback system using wearable sensors to provide the physical therapist information, in real-time during training, about quality of head and trunk movements during prescribed exercises. 160 individuals with subacute mTBI within 2-12 weeks of the injury will be randomly assigned to receive earlier onset of physical therapy (n=80) right away or be randomly assigned to receive later rehabilitation 6 weeks after enrollment in the standard of care physical therapy group (n=80). A subgroup of participants in the earlier physical therapy (n=40) and standard of care physical therapy (n=40) will be randomly assigned to home monitoring. The participants in the home monitoring subgroups will wear wireless sensors while completing the rehabilitation program to better inform the physical therapist of their progress. The outcome measures will consist of a battery of self-reported questionnaires, and balance and gait measures and will be tested at Pre I (baseline), Pre 2 (6 weeks after baseline for the later physical therapy group), Post (after the intervention), and Retention (6 month follow-up). Peripheral vestibular and ocular motor assessments will occur at the baseline visit only. The central hypothesis is that rehabilitation after mTBI is suboptimal due to late initiation of and inadequate performance of exercises that do not adequately challenge vestibular and sensory integration function. The long-term goal is to clarify best practices for the rehabilitation of balance deficits in people with mTBI by comparing earlier vs later (standard of care) initiation of physical therapy with and without wearable sensors on balance deficits after mTBI. The findings from this research could be very readily adopted into military protocols for post-mTBI care and have the potential to produce better balance rehabilitation and quality of life for mTBI patients and their families.

Interventions

Timing of RehabilitationBEHAVIORAL

Participants in the Earlier Physical Therapy group will start physical therapy within a week of enrollment and baseline testing. Participants allocated to the Later Physical Therapy group will wait 6 weeks after enrollment and baseline testing before starting physical therapy, and re-test on study outcomes before starting physical therapy. Both groups will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each session will last 60 minutes and consist of cardiovascular, cervical spine, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for 30 minutes with similar subcategories from the in-person sessions. Both the in-person physical therapy and home exercises will be individualized and progressive at the discretion of the physical therapist depending on the performance of the participant.

BiofeedbackBEHAVIORAL

Wearable sensors measure movement during the home exercise program for later feedback.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Inclusion criteria will consist of being 1) 18-60 years of age; 2) having no more than minimal cognitive impairment as assessed by the Short Blessed test; 3) having a physician-diagnosed mTBI and being within 2-12 weeks of the injury; and 4) endorsing ≥1 on either balance, dizziness, nausea, headache, or vision problems on the symptom evaluation scale from the Sport Concussion Assessment Tool (SCAT 5) and a total symptom severity score ≥15. Exclusion Criteria: * Exclusion criteria will consist of: 1) having other musculoskeletal, neurological, or sensory deficits that could explain their dysfunction other than mTBI; 2) having moderate to severe substance use disorder within the past month; 3) experiencing severe pain during the evaluation (≥7/10 subjective rating), 4) are pregnant; and 5) are currently being treated by vestibular physical therapy; All participants will be asked to refrain from taking drugs that may influence balance including sedating antihistamines, benzodiazepines, sedatives, narcotic pain medications, and alcohol for at least 24 hours prior to testing.

Outcomes

Primary Outcomes

Dizziness Handicap Inventory (DHI)

Self-rated questionnaire for dizziness impairment rated on a 3-point scale (0: no; 2: sometimes; 4: always) with a maximum score of 100. Higher scores indicate worse outcome.

Time frame: Earlier Physical Therapy (PT) Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

Secondary Outcomes

Neurobehavioral Symptom Inventory (NSI)

Self-rated questionnaire (\~5 minutes) for symptom severity on a scale from 0 (none) to 4 (very severe) with a maximum score of 88. High scores indicate worse outcomes.