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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 is a NA study that has completed, run by Oregon Health and Science University. The registered enrollment target is 203 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03479541
The ClinicalTrials.gov registry entry for NCT03479541 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 203 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Biofeedback is the first listed.
NCT03479541 reports 0 study locations.
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.
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