Objective Dual-task Turning Measures for Return-to-duty Assessments (reTURN)

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Balance; Veterans; Mobility; Mild Traumatic Brain Injury; Gait

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03892291

18749

W81XWH1820049 (Other Grant/Funding Number)

Details and patient eligibility

About

The overall objective is to evaluate objective dual-task turning measures for use as rehabilitative outcomes and as tools for return-to-duty assessments in individuals with mild traumatic brain injury (mTBI).This project consists of three goals examining the I) Diagnostic Accuracy, II) Predictive Capacity, and III) Responsiveness to Intervention of dual task turning measures in individuals with mTBI.

The investigators hypothesize that objective measures of dual-task turning will have high diagnostic accuracy, predictive capacity, and responsiveness to intervention in people with mTBI.

Full description

The purpose of this project is to expand the investigators' prior preliminary work on wearable sensors to evaluate objective dual-task turning measures for use as rehabilitative outcomes and as tools for objective return-to-duty assessments following mild traumatic brain injury (mTBI). The investigators will assess the diagnostic accuracy, predictive capacity, and responsiveness to intervention of measures obtained from clinically feasible, dual-task turning tasks in an effort to evaluate the utility of turning measures for clinical return-to-duty decisions.

This study is divided into two phases. For phase one, participants will be recruited from the general populations surrounding four sites (Oregon Health & Science University, the University of Utah, Courage Kenny Research Center, and Fort Sam Houston), including active duty service members at Fort Sam Houston. For phase two, participants will be recruited from active duty service members referred to military medical treatment facilities (Warrior Recovery Center, Madigan Army Medical Center) for vestibular rehabilitation following mTBI.

Phase One: Fifty civilian individuals with mTBI, 50 healthy control individuals, and 40 healthy control active duty service members will be recruited for phase one. Participants will complete a battery of clinical, neuropsychological, and balance tests, including three clinically feasible turning tasks while wearing inertial sensors. The investigators will evaluate the capability of objective, dual-task turning measures to discriminate between healthy controls and people with chronic mTBI, determine clinically relevant measures of dual-task turning based on clinometric properties (e.g., minimum detectable change), and determine whether active-duty SMs perform dual-task turning tasks differently than civilians, assess the capacity of dual-task turning measures to predict performance in a civilian-relevant task, and assess the capacity of dual-task turning measures to predict performance in a military-relevant task.

Phase Two: Forty active-duty service members with mTBI referred to vestibular rehabilitation at the Warrior Recovery Center or Madigan Army Medical Center will be recruited for phase two. Participants will complete a selected turning task from phase one at the beginning and end of the treatment. The investigators will determine the clinically important difference of turning outcomes and compare the effect of rehabilitation to the minimum detectable change for each outcome.

Enrollment: 185 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria.

Participants may be active duty (at FSH), Veterans or non-Veterans or a civilian and must:

1. have a diagnosis of mTBI based upon VA/DoD criteria
2. be between 18-50 years-old,
3. be outside of the acute stage (> 3 weeks post-concussion) according to the VA/DoD clinical practice guidelines but within 3 years of their most recent mTBI and still reporting symptoms.

Exclusion criteria.

Participants must not:

1. have had or currently have any other injury, medical, or neurological illness that could potentially explain balance deficits (e.g., central or peripheral nervous system disease, stroke, greater than mild TBI, lower extremity amputation, recent lower extremity or spine orthopedic injury requiring a profile)
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 validity of data collection or safety during study,
4. be in significant pain during the evaluation (7/10 by patient subjective report),
5. be a pregnant female (balance considerations), or
6. unable to communicate in English.

Trial design

185 participants in 4 patient groups

Civilian mTBI

Description:

Civilians with persistent symptoms from mTBI

Civilian Control

Description:

Civilian healthy controls

Active Duty Control

Description:

Active duty service member healthy controls

Active Duty mTBI

Description:

Active duty service members with persistent symptoms from mTBI who are referred for physical therapy due to their symptoms