Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · Apr 18, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how wearable technology can help assess and treat people with mild traumatic brain injuries (mTBI), including concussions. The researchers believe that traditional methods may not catch all the subtle issues patients face after an injury. By using wearable sensors, they aim to provide real-time feedback to participants during physical therapy. This feedback will help improve movement quality while performing exercises related to balance and walking. The study will compare this new approach with a standard rehabilitation program to see which is more effective.

To join the study, participants must be between 18 and 50 years old, have a diagnosed mTBI, and still be experiencing symptoms. They need to be able to stand without help for at least 10 minutes and must not have any other conditions that could affect balance or vision. Participants can expect to receive physical therapy aimed at improving their balance, with the added benefit of personalized feedback from the wearable technology. This research could lead to better treatment options for mTBI and help healthcare providers create effective rehabilitation guidelines in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * For all Aims, participants may be either civilians, active duty military, or Veterans, and must:
• • 1. have a diagnosis of mTBI based on VA/DoD criteria
• • 2. be between 18-60 years old,
• • 3. be able to stand unassisted for 10 minutes at a time
• • 4. be outside of the acute stage (\> 2 weeks post-concussion) but within 6 months of their most recent mTBI and still reporting symptoms
• • 5. have at least some measurable deficit in Vestibular/Ocular categories based on Concussion Profile Screen
• • 6. have sufficient vision (corrected or uncorrected) for unassisted reading and performance of everyday personal tasks and independent community ambulation
• • 7. have adequate hearing (without amplification) adequate for engaging in close-range personal or telephone conversation.
• Exclusion Criteria:
• * Participants must not:
• • 1. have had or currently have any other injury, medical, or neurological illness that could potentially explain balance or vision deficits (e.g., CNS disease, stroke, epilepsy, greater than mild TBI, Meniere's, bilateral vestibular loss, recent lower extremity or spine orthopedic injury requiring a profile) this includes unresolved symptoms from previous concussions
• • 2. meet criteria for moderate to severe substance-use disorder within the past month, as defined by DSM-V
• • 3. display behavior that would significantly interfere with the validity of data collection or safety during the study
• • 4. be in significant pain during the evaluation (\> 7/10 by patient subjective report)
• • 5. be a pregnant female (balance considerations)
• • 6. been hospitalized for any brain injuries (separate from the emergency department)
• • 7. have significant joint pain or recent musculoskeletal injury that limits walking or mobility
• • 8. have had any major surgeries in the past year or amputation
• • 9. use an assistive device
• • 10. unable to stand barefoot
• • 11. currently receiving rehabilitation services for their mTBI or injuries related to their concussion (if rehabilitation has been completed more than 1 month ago participants may still be included).