N/A
N=203
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
Bottom Line
View on ClinicalTrials.gov: NCT03479541 ↗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
| Outcome | Result | p-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.
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.