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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorOregon Health and Science University

About this trial

Current clinical assessment tools are often not sensitive enough to detect and treat some subtle (yet troubling) problems after mTBI. In this study, the investigators will use wearable sensors to both assess and treat people with mTBI. Specifically, the investigators will provide immediate feedback, with visual and/or auditory, on movement quality during physical therapy. This immediate feedback on performance may improve outcomes as the investigators will measure multiple body segments including head movements simultaneously with balance and walking exercises. Such complex movements are needed for safe return to high level activity and military duty. The investigators will test this approach against a standard vestibular rehabilitation program. There are few potential risks to this study such as increasing symptoms and a small fall risk. Benefits include physical therapy for balance problems regardless of therapy with or without biofeedback. An indirect benefit is to have data on correct dosage of physical therapy. The investigators will also distinguish which concussion subtype profiles benefit most from physical therapy. This will help healthcare providers and patients by providing more information to help establish clinical guidelines and new tools for physical therapy.

Eligibility criteria

Qualifiers

have a diagnosis of mTBI based on VA/DoD criteria

be between 18-60 years old,

be able to stand unassisted for 10 minutes at a time

be outside of the acute stage (> 2 weeks post-concussion) but within 6 months of their most recent mTBI and still reporting symptoms

Disqualifiers

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

meet criteria for moderate to severe substance-use disorder within the past month, as defined by DSM-V

display behavior that would significantly interfere with the validity of data collection or safety during the study

be in significant pain during the evaluation (> 7/10 by patient subjective report)

Trial design

Treatments tested in this trial

  • Vestibular therapy for mTBI augmented with audio and visual real-time biofeedback
  • Vestibular therapy for mTBI

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Oregon Health and Science University

Lead sponsor

United States Department of Defense

Collaborator