Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes in mTBI?
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Oregon Health and Science University
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?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 minimal cognitive impairment as assessed by the Short Blessed test; and 3) having either a diagnosis of mild traumatic brain injury with persisting symptoms for less than or equal to 12 weeks post-injury for the mild traumatic brain injury (mTBI) group, or no history of mTBI or brain injury within the past year for the control group.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Physical Therapy (Standard of Care)Experimental Treatment1 Intervention
Two sub-arms include "Vestibular Rehabilitation " n=40, and "Vestibular Rehabilitation with Home Monitoring" n=40
Group II: Physical Therapy (Early)Experimental Treatment1 Intervention
Two sub-arms include "Vestibular Rehabilitation " n=40, and "Vestibular Rehabilitation with Home Monitoring" n=40
Rehabilitation is already approved in European Union, United States, Canada for the following indications:
πͺπΊ Approved in European Union as Rehabilitation for:
- Complex Regional Pain Syndrome (CRPS)
- Musculoskeletal disorders
- Neurological conditions
πΊπΈ Approved in United States as Rehabilitation for:
- Complex Regional Pain Syndrome (CRPS)
- Chronic pain management
- Physical disabilities
π¨π¦ Approved in Canada as Rehabilitation for:
- Complex Regional Pain Syndrome (CRPS)
- Musculoskeletal injuries
- Neurological rehabilitation
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Oregon Health & Science UniversityPortland, OR
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Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
United States Department of DefenseCollaborator