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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03892291
Acronym
reTURN
Enrollment
185
Registered
2019-03-27
Start date
2018-09-01
Completion date
2024-09-01
Last updated
2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

mild traumatic brain injury, dual-task, veterans, mobility

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.

Interventions

None listed

Sponsors

Courage Kenny Research Center
CollaboratorUNKNOWN
University of Utah
CollaboratorOTHER
Fort Sam Houston
CollaboratorUNKNOWN
Warrior Recovery Center
CollaboratorUNKNOWN
Madigan Army Medical Center
CollaboratorFED
Oregon Health and Science University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Illinois Agility Assessment15 minutesSingle & dual task
Walk and Turn5 minutesSingle & dual task; 1 minute long walk
Custom Turns Course15 minutesSingle & dual task; walking along a marked course involving turns of varying angles
Civilian Ambulatory Task10 minutesParticipants 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 Patrol10 minutesParticipants 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

MeasureTime frameDescription
Automated Neuropsychological Assessment Metric30 minutesA computer-based assessment of cognition
Vestibular Ocular Motor Screening15 minutesA screening tool used to detect signs and symptoms of a concussion
Neurobehavioral Symptom Inventory4 minutes22-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.
Functional Gait Assessment15 minutesAssessment of postural stability during walking tasks
Revised HiMAT15 minutesA mobility assessment tool that involves various types of locomotion
Dizziness Handicap Inventory4 minutes25-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 Injury10 minutes37-item patient-reported questionnaire of health-related quality of life after a brain injury
Post-Traumatic Stress Disorder Checklist4 minutes17-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
Ohio State University TBI Identification Method8 minutesA standardized procedure for determining a person's TBI history

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026