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

NCT03892291 | Completed

• 2 other identifiers: 18749W81XWH1820049
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Illinois Agility Assessment

  Single \& dual task

  15 minutes

• Walk and Turn

  Single \& dual task; 1 minute long walk

  5 minutes

• Custom Turns Course

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

  15 minutes

• Civilian Ambulatory Task

  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

  10 minutes

• Simulated Urban Combat Patrol

  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.

  10 minutes

Secondary Outcomes (9)

• Neurobehavioral Symptom Inventory

  4 minutes

• Dizziness Handicap Inventory

  4 minutes

• Quality of Life after Brain Injury

  10 minutes

• Post-Traumatic Stress Disorder Checklist

  4 minutes

• Ohio State University TBI Identification Method

  8 minutes

Study Arms (4)

Civilian mTBI

Civilians with persistent symptoms from mTBI

Civilian Control

Civilian healthy controls

Active Duty Control

Active duty service member healthy controls

Active Duty mTBI

Active duty service members with persistent symptoms from mTBI who are referred for physical therapy due to their symptoms

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Courage Kenny Research Center: collaborator
• University of Utah: collaborator
• Fort Sam Houston: collaborator
• Warrior Recovery Center: collaborator
• Madigan Army Medical Center: collaborator

Study Sites (6)

Warrior Recovery Clinic

Fort Carson, Colorado, 80913, United States

Location

Courage Kenny Research Center

Minneapolis, Minnesota, 55422, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

Fort Sam Houston

San Antonio, Texas, 78234, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Madigan Army Medical Center

Lakewood, Washington, 98431, United States

Location

Related Publications (6)

• 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.

  PMID: 29078732 BACKGROUND

• 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.

  PMID: 23766395 BACKGROUND

• 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.

  PMID: 28540448 BACKGROUND

• 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.

  PMID: 36538333 DERIVED

• 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.

  PMID: 35067602 DERIVED

• 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.

  PMID: 33519659 DERIVED

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Laurie King

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 27, 2019
• Study Start: September 1, 2018
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)