- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03892291
Objective Dual-task Turning Measures for Return-to-duty Assessments (reTURN)
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Laurie King, PhD, PT
- Phone Number: 5034182602
- Email: kingla@ohsu.edu
Study Contact Backup
- Name: Shelby Martin
- Phone Number: 5034182602
- Email: martish@ohsu.edu
Study Locations
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Colorado
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Fort Carson, Colorado, United States, 80913
- Warrior Recovery Clinic
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Minnesota
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Minneapolis, Minnesota, United States, 55422
- Courage Kenny Research Center
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Oregon
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Portland, Oregon, United States, 97239-3098
- Oregon Health & Science University
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Texas
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San Antonio, Texas, United States, 78234
- Fort Sam Houston
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Utah
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Salt Lake City, Utah, United States, 84112
- University of Utah
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Washington
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Lakewood, Washington, United States, 98431
- Madigan Army Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Across all sites, Phase One will include 50 civilians with persistent symptoms from mTBI, 50 civilian healthy controls, and 40 active duty SM healthy controls in total. Three non-military sites will test civilians. A fourth military site (FSH) will enroll and test 40 healthy active duty SMs across a range of military experience and ability levels.
Subjects for Phase Two will include 40 active duty SMs with persistent symptoms from mTBI who are referred for physical therapy due to their symptoms. Participants will be recruited from two military medical centers specializing in the rehabilitation of active duty personnel after mTBI, WRC at Fort Carson and MAMC at Joint Base Lewis-McChord. Each site will recruit 20 participants for Aim III.
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Civilian mTBI
Civilians with persistent symptoms from mTBI
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Civilian Control
Civilian healthy controls
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Active Duty Control
Active duty service member healthy controls
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Active Duty mTBI
Active duty service members with persistent symptoms from mTBI who are referred for physical therapy due to their symptoms
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Illinois Agility Assessment
Time Frame: 15 minutes
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Single & dual task
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15 minutes
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Walk and Turn
Time Frame: 5 minutes
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Single & dual task; 1 minute long walk
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5 minutes
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Custom Turns Course
Time Frame: 15 minutes
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Single & dual task; walking along a marked course involving turns of varying angles
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15 minutes
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Civilian Ambulatory Task
Time Frame: 10 minutes
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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
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10 minutes
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Simulated Urban Combat Patrol
Time Frame: 10 minutes
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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.
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10 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurobehavioral Symptom Inventory
Time Frame: 4 minutes
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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.
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4 minutes
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Dizziness Handicap Inventory
Time Frame: 4 minutes
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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).
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4 minutes
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Quality of Life after Brain Injury
Time Frame: 10 minutes
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37-item patient-reported questionnaire of health-related quality of life after a brain injury
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10 minutes
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Post-Traumatic Stress Disorder Checklist
Time Frame: 4 minutes
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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
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4 minutes
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Ohio State University TBI Identification Method
Time Frame: 8 minutes
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A standardized procedure for determining a person's TBI history
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8 minutes
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Automated Neuropsychological Assessment Metric
Time Frame: 30 minutes
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A computer-based assessment of cognition
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30 minutes
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Vestibular Ocular Motor Screening
Time Frame: 15 minutes
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A screening tool used to detect signs and symptoms of a concussion
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15 minutes
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Revised HiMAT
Time Frame: 15 minutes
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A mobility assessment tool that involves various types of locomotion
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15 minutes
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Functional Gait Assessment
Time Frame: 15 minutes
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Assessment of postural stability during walking tasks
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15 minutes
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Laurie King, Oregon Health and Science University
Publications and helpful links
General Publications
- Fino PC, Parrington L, Walls M, Sippel E, Hullar TE, Chesnutt JC, King LA. Abnormal Turning and Its Association with Self-Reported Symptoms in Chronic Mild Traumatic Brain Injury. J Neurotrauma. 2018 May 15;35(10):1167-1177. doi: 10.1089/neu.2017.5231. Epub 2018 Mar 23.
- Scherer MR, Weightman MM, Radomski MV, Davidson LF, McCulloch KL. Returning service members to duty following mild traumatic brain injury: exploring the use of dual-task and multitask assessment methods. Phys Ther. 2013 Sep;93(9):1254-67. doi: 10.2522/ptj.20120143. Epub 2013 Jun 13.
- King LA, Mancini M, Fino PC, Chesnutt J, Swanson CW, Markwardt S, Chapman JC. Sensor-Based Balance Measures Outperform Modified Balance Error Scoring System in Identifying Acute Concussion. Ann Biomed Eng. 2017 Sep;45(9):2135-2145. doi: 10.1007/s10439-017-1856-y. Epub 2017 May 24.
- Parrington L, King LA, Hoppes CW, Klaiman MJ, Michielutti P, Fino PC, Dibble LE, Lester ME, Weightman MM. Exploring Vestibular Ocular Motor Screening in Adults With Persistent Complaints After Mild Traumatic Brain Injury. J Head Trauma Rehabil. 2022 Sep-Oct 01;37(5):E346-E354. doi: 10.1097/HTR.0000000000000762. Epub 2022 Jan 20.
- Fino PC, Weightman MM, Dibble LE, Lester ME, Hoppes CW, Parrington L, Arango J, Souvignier A, Roberts H, King LA. Objective Dual-Task Turning Measures for Return-to-Duty Assessment After Mild Traumatic Brain Injury: The ReTURN Study Protocol. Front Neurol. 2021 Jan 15;11:544812. doi: 10.3389/fneur.2020.544812. eCollection 2020.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18749
- W81XWH1820049 (Other Grant/Funding Number: Department of Defense)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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