Objective Dual-task Turning Measures for Return-to-duty Assessments

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Objective Dual-task Turning Measures for Return-to-duty Assessments

Conditions
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Mild Traumatic Brain Injury, Gait, Balance, Veterans, Mobility

Participation Criteria
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Eligibility Criteria
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Inclusion criteria. Participants may be active duty (at FSH), Veterans or non-Veterans or a civilian and must: have a diagnosis of mTBI based upon VA/DoD criteria be between 18-50 years-old, 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: 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) 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 validity of data collection or safety during study, be in significant pain during the evaluation (7/10 by patient subjective report), be a pregnant female (balance considerations), or unable to communicate in English.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Civilian mTBI<br>Civilians with persistent symptoms from mTBI | |
| Civilian Control<br>Civilian healthy controls | |
| Active Duty Control<br>Active duty service member healthy controls | |
| Active Duty mTBI<br>Active duty service members with persistent symptoms from mTBI who are referred for physical therapy due to their symptoms | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Illinois Agility Assessment | Single & dual task | 15 minutes | 
| Walk and Turn | Single & dual task; 1 minute long walk | 5 minutes | 
| Custom Turns Course | Single & dual task; walking along a marked course involving turns of varying angles | 15 minutes | 
| Civilian Ambulatory Task | Participants will asked to follow a series of written directions that involves walking in uncontrolled pedestrian environments. Subjects will be given a walking route through written instructions and landmark-based directions to follow. The walking route will require participants to ambulate around public areas and will take approximately 10 minutes to complete. Participants will be required to navigate through crowded hallways, ascend and descend stairs, and scan for pedestrians and/or other obstacles. The total time to complete the task will be recorded | 10 minutes | 
| Simulated Urban Combat Patrol | Participants will complete a simulated patrol task within a small room partitioned into two areas. Each area will contain several targets illuminated with LED lights and containing infrared (IR) sensing diodes. Participants will be instructed to enter the room, and tag all red LEDs by pointing a laser at the IR receiver located next to the LED. Participants will use a trigger-activated laser (i.e., laser gun) to tag targets. Upon being tagged with the laser, the white LEDs surrounding the target will activate to indicate the target has been cleared. The total time to complete the task will be recorded. Following the task, participants will also be asked to recount the number targets in each room. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurobehavioral Symptom Inventory | 22-item patient-reported questionnaire assessing cognitive, affective, somatic, and vestibular symptoms. Total scores range: 0-88. Subscores [cognitive, affective, somatic, and vestibular] ranges: 0-22 each. The higher the value, the worse the outcome. | 4 minutes | 
| Dizziness Handicap Inventory | 25-item patient-reported questionnaire related to dizziness, scored based on functional, emotional, and physical domains (and totaled). The higher the value, the worse the outcome. Scores range from 0 to 100 (28 possible points for physical, 36 for emotional, and 36 for functional). | 4 minutes | 
| Quality of Life after Brain Injury | 37-item patient-reported questionnaire of health-related quality of life after a brain injury | 10 minutes | 
| Post-Traumatic Stress Disorder Checklist | 17-item patient-reported questionnaire related to PTSD. Each item can be rated on a scale of 1 to 5. The score is totaled at the end. The higher the score, the worse the outcome. Scores range from 17 to 85 | 4 minutes | 
| Ohio State University TBI Identification Method | A standardized procedure for determining a person's TBI history | 8 minutes | 
| Automated Neuropsychological Assessment Metric | A computer-based assessment of cognition | 30 minutes | 
| Vestibular Ocular Motor Screening | A screening tool used to detect signs and symptoms of a concussion | 15 minutes | 
| Revised HiMAT | A mobility assessment tool that involves various types of locomotion | 15 minutes | 
| Functional Gait Assessment | Assessment of postural stability during walking tasks | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild traumatic brain injury, dual-task, veterans, mobility