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NCT06381674 · ClinicalTrials.gov registry record · NA

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

A NA study of Rehabilitation and Mild Traumatic Brain Injury, Concussion, sponsored by Oregon Health and Science University.

Recruiting
Registry status
NA
Development phase
100
Enrollment target
3
Study locations

NCT06381674 is a NA study of Rehabilitation and Mild Traumatic Brain Injury, Concussion that is actively recruiting participants, run by Oregon Health and Science University. The registered enrollment target is 100 participants, below the 159-participant average among 15 other Rehabilitation trials with a reported enrollment target (37% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT06381674, a NA study of Rehabilitation and Mild Traumatic Brain Injury, Concussion, is actively recruiting participants, sponsored by Oregon Health and Science University.

RECRUITING
Registry status
NA
Development phase
100 participants
Enrollment target
3
Study locations

Study 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.

Interventions

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

Study Locations (3)

Oregon

  • Oregon Health & Science University - Portland

Texas

  • Fort Sam Houston - San Antonio

Utah

  • University of Utah - Salt Lake City

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2024-06-13
Est. Completion 2028-09-30
Phase NA

What the Registry Record Tells You About NCT06381674

The ClinicalTrials.gov registry entry for NCT06381674 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 159-participant average among 15 other Rehabilitation trials with a reported enrollment target (37% lower). The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Rehabilitation appearing as the primary indexed condition, and to 2 interventions - of which Vestibular therapy for mTBI augmented with audio and visual real-time biofeedback is the first listed.

NCT06381674 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Oregon, Texas, Utah.

Frequently Asked Questions

What is clinical trial NCT06381674 about?

NCT06381674 is a clinical study titled "Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation". 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,...

What is the current status of trial NCT06381674?

This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2024-06-13. Estimated completion is 2028-09-30.

What conditions does trial NCT06381674 study?

This clinical trial studies the following conditions: Rehabilitation, Mild Traumatic Brain Injury, Concussion, Balance Impairment.

What interventions are being tested in trial NCT06381674?

The interventions under investigation include: Vestibular therapy for mTBI augmented with audio and visual real-time biofeedback (OTHER), Vestibular therapy for mTBI (OTHER).

Who is sponsoring clinical trial NCT06381674?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06381674 being conducted?

This trial has 3 study locations across Oregon, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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