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

Not Applicable

Completed

Conditions: Mild Traumatic Brain Injury
Veterans
Balance; Distorted
Quality of Life
Gait, Unsteady

Registration Number: NCT03479541

Lead Sponsor: Oregon Health and Science University

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 203

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dizziness Handicap Inventory (DHI)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Neurobehavioral Symptom Inventory (NSI)	Earlier 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)	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.
Quality of Life After Brain Injury (QOLIBRI)	Earlier 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)	Self-rated questionnaire for quality of life questioning satisfaction on a scale from 0 (not at all) to 4 (very). Scores are transformed to a scale of 0 to 100. Lower scores indicate worse outcomes.
Vestibular/Ocular-Motor Screening (VOMS) Tool	Earlier 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)	Physical assessment (\~10 minutes) to assess the function of the vestibular- and ocular-motor system, and clinically reporting symptoms of headache, dizziness, nausea, and fogginess during each visual task on a 10-point scale (0: no symptoms; 10 severe symptoms). The total symptom provocation change scores range from 0 to 280. High scores indicate worse outcomes.
Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise	Earlier 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)	Physical assessment (\~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to internal sensory noise. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed.
Patient Global Impression of Change (PGIC)	Earlier PT Group: Post PT (week 7) / Later PT Group: Post PT (week 14)	This single questionnaire will ask the participant to rate how they perceive their health has changed over the course of treatment. Scores range from 1 to 7 with lower scores indicating worse performance.
Return to Activity Question	Earlier 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)	One question asking participants how recovered they feel on a 0 (not at all recovered) to 100% (fully recovered and returned to pre-injury level) scale. Lower scores indicate worse outcomes.
Mini-Balance Evaluation Systems Test (Mini-BESTest)	Earlier 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)	Physical assessment (\~20 minutes) to quantify balance and clinically scored on a 3-point scale (0: severe; 2: normal) with a maximum score of 28. Lower scores indicate worse outcomes.
Instrumented Sway	Earlier 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)	Participants stand with feet together with eyes closed on a firm (EcFi) and Foam (EcFo) surface for 30 seconds. An inertial sensor around the waist measures the sway area. Larger areas indicate worse performance.We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed.
Instrumented Walking: Gait Speed	Earlier 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)	Physical assessment using wearable inertial sensors to quantify gait kinematics when walking at a self-selected pace in a straight line (9m) with and without the auditory Stroop. Gait speed at enrollment (m/s). Slower gait speeds and slower turning velocity indicate worse outcomes.
Instrumented Walking: 180 Degree Turn Velocity	Earlier 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)	Physical assessment using wearable inertial sensors to quantify gait kinematics when walking at a self-selected pace in a straight line (9m) with and without the auditory Stroop. Measure: 180-degree turning speed. Slower turning velocities indicate worse outcomes. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed.
Instrumented Walking: Percentage of Double Support of Gait Cycle	Earlier 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)	Physical assessment using wearable inertial sensors to quantify gait kinematics when walking at a self-selected pace in a straight line (9m) with and without the auditory Stroop. Percentage of gait cycle in double support were the outcome measure. Larger percentages of double support time indicate worse outcomes.
Central Sensorimotor Integration (CSMI) Test: Time Delay	Earlier 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)	Physical assessment (\~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to calculate time delay within the neural controller. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed.
Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness	Earlier 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)	Physical assessment (\~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to calculate normalized stiffness for neural controller. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed.
Dynamic Visual Acuity (DVA)	Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Pre (week 7), and Post Physical Therapy (week 14)	Physical assessment that assesses gaze stability during head rotations (horizontal and vertical) relative to head-stationary visual acuity. Higher scores indicate worse outcome.
Modified Balance Error Scoring System (mBESS)	Earlier 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)	Physical assessment (\~5 min) that is clinically scored on a scale from 0-10 (0: no errors; 10: 10 or more errors) for each of the three conditions. High scores indicate worse outcomes.
Automated Neuropsychological Assessment Metrics (ANAM)	Earlier 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)	20-minute Computer-based test of cognition. Composite scores range from -4 to +4. Lower scores indicate worse outcome.
Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting	Earlier 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)	Physical assessment (\~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to calculate sensory weighting. This outcome is unitless for the weights as they are percentage values (0-1). We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed.
Central Sensorimotor Integration (CSMI) Test: Normalized Damping	Earlier 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)	Physical assessment (\~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to calculate normalized damping for neural controller. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed.
Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway	Earlier 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)	Physical assessment (\~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to calculate evoked center-of-mass (CoM) sway. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed.
Complex Navigation Task	Earlier 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)	Physical assessment using wearable inertial sensors to quantify the average time to navigate a lap of a complex course (total 8 laps). Participants walk at a self-selected pace around the course under single-task and dual-task auditory Stroop conditions. Longer lap times indicate worse outcomes.

Trial Locations

Locations (1): Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States