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Completed

NCT Number: NCT03892291

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Warrior Recovery Clinic, Fort Carson, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Illinois Agility Assessment

    Time frame: 15 minutes

    Single & dual task

  2. Walk and Turn

    Time frame: 5 minutes

    Single & dual task; 1 minute long walk

  3. Custom Turns Course

    Time frame: 15 minutes

    Single & dual task; walking along a marked course involving turns of varying angles

  4. Civilian Ambulatory Task

    Time frame: 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

  5. Simulated Urban Combat Patrol

    Time frame: 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 outcomes

  1. Neurobehavioral Symptom Inventory

    Time frame: 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.

  2. Dizziness Handicap Inventory

    Time frame: 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).

  3. Quality of Life after Brain Injury

    Time frame: 10 minutes

    37-item patient-reported questionnaire of health-related quality of life after a brain injury

  4. Post-Traumatic Stress Disorder Checklist

    Time frame: 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

  5. Ohio State University TBI Identification Method

    Time frame: 8 minutes

    A standardized procedure for determining a person's TBI history

  6. Automated Neuropsychological Assessment Metric

    Time frame: 30 minutes

    A computer-based assessment of cognition

  7. Vestibular Ocular Motor Screening

    Time frame: 15 minutes

    A screening tool used to detect signs and symptoms of a concussion

  8. Revised HiMAT

    Time frame: 15 minutes

    A mobility assessment tool that involves various types of locomotion

  9. Functional Gait Assessment

    Time frame: 15 minutes

    Assessment of postural stability during walking tasks

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Courage Kenny Research Center
  • Fort Sam Houston
  • Madigan Army Medical Center
  • University of Utah
  • Warrior Recovery Center

Registry information

Acronym: reTURN

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2019
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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