Using wearable technology to improve rehabilitation for mild traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance the assessment and treatment of mild traumatic brain injury (mTBI) by utilizing wearable sensors that provide real-time biofeedback during vestibular rehabilitation. Participants will receive immediate visual and auditory feedback on their movement quality while performing balance and walking exercises, which may lead to improved rehabilitation outcomes. The study will compare this innovative approach against standard vestibular rehabilitation methods to evaluate its effectiveness. By focusing on the specific subtypes of mTBI that affect balance and gait, the research seeks to tailor rehabilitation to individual patient needs.

Why it matters

Who can join: the full rules

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 that impairs mobility) 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).

Where it's running

• Oregon Health & Science University
  Portland, Oregon, United States Recruiting
• University of Utah
  Salt Lake City, Utah, United States Recruiting
• Fort Sam Houston
  San Antonio, Texas, United States Not yet recruiting

Study contacts

• Principal investigator: Laurie A King, PhD, DPT — Oregon Health and Science University
• Study coordinator: Laurie A King, PhD, PT, MCR
• Email: kingla@ohsu.edu
• Phone: 503-418-2602

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.