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NCT03479541 · ClinicalTrials.gov registry record · NA
Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes in mTBI?
A NA study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- NA
- Development phase
- 203
- Enrollment target
NCT03479541: Completed NA study, sponsored by Oregon Health and Science University.
NCT03479541 is a NA study that has completed, run by Oregon Health and Science University. The registered enrollment target is 203 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03479541, a NA study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- NA
- Development phase
- 203 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BEHAVIORAL Biofeedback
- BEHAVIORAL Timing of Rehabilitation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2018-07-15 |
| Est. Completion | 2023-09-30 |
| Phase | NA |
What the finished NCT03479541 record still lists
NCT03479541 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Biofeedback is the first listed.
NCT03479541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03479541 about?
NCT03479541 is a clinical study titled "Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes in mTBI?". 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 ...
What is the current status of trial NCT03479541?
This trial is currently completed. It is a NA study. The enrollment target is 203 participants. The study started on 2018-07-15. Estimated completion is 2023-09-30.
What interventions are being tested in trial NCT03479541?
The interventions under investigation include: Biofeedback (BEHAVIORAL), Timing of Rehabilitation (BEHAVIORAL).
Who is sponsoring clinical trial NCT03479541?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03479541's enrollment target sits among peer trials
203 504th of 2000 higher than 1,496 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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