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

Mild Traumatic Brain Injury Clinical Trial

— reTURN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03892291
• Other study ID #: 18749
• Secondary ID: W81XWH1820049
• Status: Active, not recruiting
• Start date: September 1, 2018
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Balance
• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Gait
• Mild Traumatic Brain Injury
• Mobility
• Veterans

Locations

Country	Name	City	State
United States	Warrior Recovery Clinic	Fort Carson	Colorado
United States	Madigan Army Medical Center	Lakewood	Washington
United States	Courage Kenny Research Center	Minneapolis	Minnesota
United States	Oregon Health & Science University	Portland	Oregon
United States	University of Utah	Salt Lake City	Utah
United States	Fort Sam Houston	San Antonio	Texas

Sponsors (6)

Lead Sponsor	Collaborator
Oregon Health and Science University	Courage Kenny Research Center, Fort Sam Houston, Madigan Army Medical Center, University of Utah, Warrior Recovery Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Illinois Agility Assessment	Single & dual task	15 minutes
Primary	Walk and Turn	Single & dual task; 1 minute long walk	5 minutes
Primary	Custom Turns Course	Single & dual task; walking along a marked course involving turns of varying angles	15 minutes
Primary	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
Primary	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	Neurobehavioral Symptom Inventory	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.	4 minutes
Secondary	Dizziness Handicap Inventory	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).	4 minutes
Secondary	Quality of Life after Brain Injury	37-item patient-reported questionnaire of health-related quality of life after a brain injury	10 minutes
Secondary	Post-Traumatic Stress Disorder Checklist	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	4 minutes
Secondary	Ohio State University TBI Identification Method	A standardized procedure for determining a person's TBI history	8 minutes
Secondary	Automated Neuropsychological Assessment Metric	A computer-based assessment of cognition	30 minutes
Secondary	Vestibular Ocular Motor Screening	A screening tool used to detect signs and symptoms of a concussion	15 minutes
Secondary	Revised HiMAT	A mobility assessment tool that involves various types of locomotion	15 minutes
Secondary	Functional Gait Assessment	Assessment of postural stability during walking tasks	15 minutes