Status:
COMPLETED
Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes in mTBI?
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
United States Department of Defense
Medical Research Foundation, Oregon
Conditions:
Mild Traumatic Brain Injury
Balance; Distorted
Eligibility:
All Genders
18-60 years
Phase:
NA
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 an...
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 ear...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT03479541
Start Date
July 15 2018
End Date
September 30 2023
Last Update
June 24 2025
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098