Clinical trial NCT03892291: Objective Dual-task Turning Measures for Return-to-duty Assessments
Official title: Objective Dual-task Turning Measures for Return-to-duty Assessments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Traumatic Brain Injury
Gait
Balance
Veterans
Mobility
Keywords: mild traumatic brain injury
dual-task
veterans
mobility
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Courage Kenny Research Center
name: University of Utah
name: Fort Sam Houston
name: Warrior Recovery Center
name: Madigan Army Medical Center
First posted: 2019-03-27
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Illinois Agility Assessment
timeFrame: 15 minutes
measure: Walk and Turn
timeFrame: 5 minutes
measure: Custom Turns Course
timeFrame: 15 minutes
measure: Civilian Ambulatory Task
timeFrame: 10 minutes
measure: Simulated Urban Combat Patrol
timeFrame: 10 minutes
Secondary outcomes:
measure: Neurobehavioral Symptom Inventory
timeFrame: 4 minutes
measure: Dizziness Handicap Inventory
timeFrame: 4 minutes
measure: Quality of Life after Brain Injury
timeFrame: 10 minutes
measure: Post-Traumatic Stress Disorder Checklist
timeFrame: 4 minutes
measure: Ohio State University TBI Identification Method
timeFrame: 8 minutes
measure: Automated Neuropsychological Assessment Metric
timeFrame: 30 minutes
measure: Vestibular Ocular Motor Screening
timeFrame: 15 minutes
measure: Revised HiMAT
timeFrame: 15 minutes
measure: Functional Gait Assessment
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Fort Carson
country: United States
facility: Warrior Recovery Clinic
state: Colorado
city: Minneapolis
country: United States
facility: Courage Kenny Research Center
state: Minnesota
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: San Antonio
country: United States
facility: Fort Sam Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Lakewood
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Oregon Health and Science University
name: Laurie King
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.