Objective Dual-task Turning Measures for Return-to-duty Assessments
- Conditions
- GaitBalanceMobilityMild Traumatic Brain InjuryVeterans
- Registration Number
- NCT03892291
- Lead Sponsor
- Oregon Health and Science University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 140
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Illinois Agility Assessment 15 minutes Single \& dual task
Walk and Turn 5 minutes Single \& dual task; 1 minute long walk
Custom Turns Course 15 minutes Single \& dual task; walking along a marked course involving turns of varying angles
Civilian Ambulatory Task 10 minutes 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
Simulated Urban Combat Patrol 10 minutes 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.
- Secondary Outcome Measures
Name Time Method Ohio State University TBI Identification Method 8 minutes A standardized procedure for determining a person's TBI history
Automated Neuropsychological Assessment Metric 30 minutes A computer-based assessment of cognition
Post-Traumatic Stress Disorder Checklist 4 minutes 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
Neurobehavioral Symptom Inventory 4 minutes 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.
Vestibular Ocular Motor Screening 15 minutes A screening tool used to detect signs and symptoms of a concussion
Dizziness Handicap Inventory 4 minutes 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).
Quality of Life after Brain Injury 10 minutes 37-item patient-reported questionnaire of health-related quality of life after a brain injury
Revised HiMAT 15 minutes A mobility assessment tool that involves various types of locomotion
Functional Gait Assessment 15 minutes Assessment of postural stability during walking tasks
Trial Locations
- Locations (6)
Warrior Recovery Clinic
🇺🇸Fort Carson, Colorado, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Courage Kenny Research Center
🇺🇸Minneapolis, Minnesota, United States
Fort Sam Houston
🇺🇸San Antonio, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Madigan Army Medical Center
🇺🇸Lakewood, Washington, United States