Objective Dual-task Turning Measures for Return-to-duty Assessments
NCT ID: NCT03892291
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
185 participants
OBSERVATIONAL
2018-09-01
2024-09-01
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Civilian mTBI
Civilians with persistent symptoms from mTBI
No interventions assigned to this group
Civilian Control
Civilian healthy controls
No interventions assigned to this group
Active Duty Control
Active duty service member healthy controls
No interventions assigned to this group
Active Duty mTBI
Active duty service members with persistent symptoms from mTBI who are referred for physical therapy due to their symptoms
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
50 Years
ALL
Yes
Sponsors
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Courage Kenny Research Center
UNKNOWN
University of Utah
OTHER
Fort Sam Houston
UNKNOWN
Warrior Recovery Center
UNKNOWN
Madigan Army Medical Center
FED
Oregon Health and Science University
OTHER
Responsible Party
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Laurie King
Associate Professor
Principal Investigators
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Laurie King
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Warrior Recovery Clinic
Fort Carson, Colorado, United States
Courage Kenny Research Center
Minneapolis, Minnesota, United States
Oregon Health & Science University
Portland, Oregon, 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
Countries
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References
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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.
Fino PC, Michielutti PG, Pelo R, Parrington L, Dibble LE, Hoppes CW, Lester ME, Weightman MM, King LA. A Hybrid Assessment of Clinical Mobility Test Items for Evaluating Individuals With Mild Traumatic Brain Injury. J Neurol Phys Ther. 2023 Apr 1;47(2):84-90. doi: 10.1097/NPT.0000000000000427. Epub 2022 Dec 19.
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.
Other Identifiers
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W81XWH1820049
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
18749
Identifier Type: -
Identifier Source: org_study_id
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