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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• For all Aims, participants may be either civilians, active duty military, or Veterans, and must:

‣ 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

⁃ have at least some measurable deficit in Vestibular/Ocular categories based on Concussion Profile Screen

⁃ have sufficient vision (corrected or uncorrected) for unassisted reading and performance of everyday personal tasks and independent community ambulation

⁃ have adequate hearing (without amplification) adequate for engaging in close-range personal or telephone conversation.

Locations
United States
Oregon
Oregon Health & Science University
RECRUITING
Portland
Texas
Fort Sam Houston
NOT_YET_RECRUITING
San Antonio
Utah
University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Laurie A King, PhD, PT, MCR
kingla@ohsu.edu
503-418-2602
Backup
Maggie E Stojak, MS
stojak@ohsu.edu
971-420-4351
Time Frame
Start Date: 2024-06-13
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 100
Treatments
Experimental: Vestibular Therapy Augmented with Audio and Visual Real-Time Biofeedback
This arm will receive 12 sessions over 6-weeks of vestibular therapy for mTBI (concussion) based on clinical practice guidelines augmented with visual and audio real-time biofeedback.
Active_comparator: Vestibular Therapy-Standard of Care
This arm will receive 12 sessions of vestibular physical therapy over 6-weeks based on clinical practice guidelines for mTBI (concussion).
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov