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N/A N=203 Randomized Double-blind Treatment

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

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

Enrolled (actual)
203
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Dizziness Handicap Inventory (DHI) — 29.2; 34.9; 33.3; 32.1 score on a scale — p=0.013

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Timing of Rehabilitation (Behavioral); Biofeedback (Behavioral)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Oregon Health and Science University
Primary completion
Sep 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Dizziness Handicap Inventory (DHI)
29.2; 34.9; 33.3; 32.1; -0.202; -0.105 0.013 sig
SECONDARY
Neurobehavioral Symptom Inventory (NSI)
39.1; 43.5; 42.7; 40.9; -0.259; -0.186 0.013 sig
SECONDARY
Quality of Life After Brain Injury (QOLIBRI)
49.7; 45.7; 47.9; 46.8; 0.277; 0.179 0.010 sig
SECONDARY
Patient Global Impression of Change (PGIC)
6; 6; 6; 6 0.5158
SECONDARY
Return to Activity Question
59.8; 54.2; 54.1; 58.5; 0.277; 0.236 0.450
SECONDARY
Dynamic Visual Acuity (DVA)
1.1; 1.3; 1.4; 1.4; 0.8; 0.8 0.6039
SECONDARY
Vestibular/Ocular-Motor Screening (VOMS) Tool
14.4; 14.6; 14.9; 14.3; -0.131; -0.103 0.387
SECONDARY
Mini-Balance Evaluation Systems Test (Mini-BESTest)
24.8; 24.4; 24.4; 24.7; 0.019; 0.011 0.135
SECONDARY
Modified Balance Error Scoring System (mBESS)
6.1; 6.6; 6.6; 6.2; -0.0229; -0.0122 0.406
SECONDARY
Automated Neuropsychological Assessment Metrics (ANAM)
-0.730; -0.732; -0.787; -0.685; 0.00647; 0.00256 0.083
SECONDARY
Instrumented Sway
0.160; 0.237; 0.215; 0.198; -0.006; -0.003 0.240
SECONDARY
Complex Navigation Task
14.78; 15.30; 14.94; 15.22; -0.0322; -0.0210 0.042 sig
SECONDARY
Instrumented Walking: Gait Speed
1.313; 1.255; 1.289; 1.283; 0.00083; 0.00054 0.3226
SECONDARY
Instrumented Walking: 180 Degree Turn Velocity
208.22; 194.78; 201.2; 199.4; 0.261; 0.100 0.0742
SECONDARY
Instrumented Walking: Percentage of Double Support of Gait Cycle
19.18; 20.08; 19.88; 19.59; -0.0021; -0.0027 0.8906
SECONDARY
Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting
0.134; 0.133; 0.137; 0.130; -0.0004; -0.0002 0.013 sig
SECONDARY
Central Sensorimotor Integration (CSMI) Test: Time Delay
218.0; 211.0; 213.6; 214.2; -0.217; 0.018 <0.001 sig
SECONDARY
Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness
1.219; 1.228; 1.212; 1.234; 0.0001; -0.0002 0.237
SECONDARY
Central Sensorimotor Integration (CSMI) Test: Normalized Damping
0.469; 0.469; 0.456; 0.479; 0.0001; -0.0001 0.247
SECONDARY
Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway
0.289; 0.281; 0.308; 0.265; -0.004; -0.0004 0.003 sig
SECONDARY
Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise
0.088; 0.087; 0.092; 0.084; -0.003; 0.0002 0.031 sig

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03479541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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