RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-13
Study Completion:2028-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06381674

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * For all Aims, participants may be either civilians, active duty military, or Veterans, and must:
  2. 1. have a diagnosis of mTBI based on VA/DoD criteria
  3. 2. be between 18-50 years old,
  4. 3. be able to stand unassisted for 10 minutes at a time
  5. 4. be outside of the acute stage (\> 2 weeks post-concussion) but within 6 months of their most recent mTBI and still reporting symptoms
  6. 5. have at least some measurable deficit in Vestibular/Ocular categories based on Concussion Profile Screen
  7. 6. have sufficient vision (corrected or uncorrected) for unassisted reading and performance of everyday personal tasks and independent community ambulation
  8. 7. have adequate hearing (without amplification) adequate for engaging in close-range personal or telephone conversation.
  1. * Participants must not:
  2. 1. have had or currently have any other injury, medical, or neurological illness that could potentially explain balance or vision deficits (e.g., stroke, a more severe brain injury, recent lower extremity or spine orthopedic injury or surgery)
  3. 2. meet criteria for moderate to severe substance-use disorder within the past month, as defined by DSM-V
  4. 3. display behavior that would significantly interfere with validity of data collection or safety during study
  5. 4. be in significant pain during the evaluation (\> 7/10 by patient subjective report)
  6. 5. be a pregnant female (balance considerations)
  7. 6. been hospitalized for any brain injuries (separate from emergency department)
  8. 7. have significant joint pain or recent musculoskeletal injury that limits walking or mobility
  9. 8. have had any major surgeries in the past year or amputation
  10. 9. use an assistive device
  11. 10. unable to stand barefoot
  12. 11. currently receiving rehabilitation services for their mTBI or injuries related to their concussion

Contacts and Locations

Study Contact

Laurie A King, PhD, DPT
CONTACT
503-418-2602
kingla@ohsu.edu
Maggie E Stojak, MS
CONTACT
971-420-4351
stojak@ohsu.edu

Principal Investigator

Laurie A King, PhD, DPT
PRINCIPAL_INVESTIGATOR
Oregon Health and Science University

Study Locations (Sites)

Oregon Health & Science University
Portland, Oregon, 97239-3098
United States
Fort Sam Houston
San Antonio, Texas, 78234
United States
University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

  • Laurie A King, PhD, DPT, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-13
Study Completion Date2028-09-30

Study Record Updates

Study Start Date2024-06-13
Study Completion Date2028-09-30

Terms related to this study

Keywords Provided by Researchers

  • mild traumatic brain injury (mTBI)
  • concussion
  • vestibular
  • ocular
  • balance
  • rehabilitation
  • biofeedback
  • wearable sensors

Additional Relevant MeSH Terms

  • Mild Traumatic Brain Injury, Concussion
  • Rehabilitation
  • Balance Impairment