Mild Traumatic Brain InjuryreTURNNCT03892291
Objective Dual-task Turning Measures for Return-to-duty Assessments
An observational study of Mild Traumatic Brain Injury and Gait, run by Oregon Health and Science University at 6 sites in United States.
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)… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury, Gait, Balance
- How many people
- 185 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Sep 2018to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Warrior Recovery Clinic
Fort Carson, Colorado, 80913
Madigan Army Medical Center
Lakewood, Washington, 98431
Courage Kenny Research Center
Minneapolis, Minnesota, 55422
Oregon Health & Science University
Portland, Oregon, 97239-3098
University of Utah
Salt Lake City, Utah, 84112
Fort Sam Houston
San Antonio, Texas, 78234
About this study
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.
Read the 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.
- Conditions
- Mild Traumatic Brain Injury, Gait, Balance, Veterans, Mobility
- Keywords
- mild traumatic brain injury, dual-task, veterans, mobility
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illinois Agility Assessment
Single \& dual task
Measured: 15 minutes
Walk and Turn
Single \& dual task; 1 minute long walk
Measured: 5 minutes
Custom Turns Course
Single \& dual task; walking along a marked course involving turns of varying angles
Measured: 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
Measured: 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.
Measured: 10 minutes
Secondary outcomes (9)
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.
Measured: 4 minutes
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).
Measured: 4 minutes
Quality of Life after Brain Injury
37-item patient-reported questionnaire of health-related quality of life after a brain injury
Measured: 10 minutes
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
Measured: 4 minutes
Ohio State University TBI Identification Method
A standardized procedure for determining a person's TBI history
Measured: 8 minutes
Automated Neuropsychological Assessment Metric
A computer-based assessment of cognition
Measured: 30 minutes
Vestibular Ocular Motor Screening
A screening tool used to detect signs and symptoms of a concussion
Measured: 15 minutes
Revised HiMAT
A mobility assessment tool that involves various types of locomotion
Measured: 15 minutes
Functional Gait Assessment
Assessment of postural stability during walking tasks
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Sep 2018
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Courage Kenny Research Center, University of Utah, Fort Sam Houston, Warrior Recovery Center, Madigan Army Medical Center
- Responsible party
- Principal investigator, Laurie King, Oregon Health and Science University
- Investigators
- Laurie King, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892291
- Sponsor's protocol ID
- 18749
- Other IDs
- W81XWH1820049
- Acronym
- reTURN
- Status last verified
- Jun 2025
- First submitted
- 13 Mar 2019
- Last updated
- 6 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29078732Scherer 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.
PubMed 23766395King 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.
PubMed 28540448Weightman MM, King LA, Fino PC, Dibble LE, Pelo R, Michielutti PG, Richard H, Parrington L, Lester ME, Hoppes CW. Reconsidering Vestibular/Ocular Motor Screening Cutoff Scores for Concussion. Mil Med. 2024 Feb 27;189(3-4):e714-e720. doi: 10.1093/milmed/usad394.
PubMed 37856171Fino 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.
PubMed 36538333Parrington 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.
PubMed 35067602Fino 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.
PubMed 33519659
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Dual-task Turning Measures for Return-to-duty Assessments
- ClinicalTrials.gov ID
- NCT03892291
- Acronym / sponsor ID
- reTURN / 18749
- Conditions
- Mild Traumatic Brain Injury, Gait, Balance, Veterans, Mobility
- Keywords
- mild traumatic brain injury, dual-task, veterans, mobility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Courage Kenny Research Center, University of Utah, Fort Sam Houston, Warrior Recovery Center, Madigan Army Medical Center
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Illinois Agility Assessment
Time frame: 15 minutes
Single \& dual task
Walk and Turn
Time frame: 5 minutes
Single \& dual task; 1 minute long walk
Custom Turns Course
Time frame: 15 minutes
Single \& dual task; walking along a marked course involving turns of varying angles
Civilian Ambulatory Task
Time frame: 10 minutes
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
Simulated Urban Combat Patrol
Time frame: 10 minutes
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.
9 secondary outcomes
Neurobehavioral Symptom Inventory
Time frame: 4 minutes
Dizziness Handicap Inventory
Time frame: 4 minutes
Quality of Life after Brain Injury
Time frame: 10 minutes
Post-Traumatic Stress Disorder Checklist
Time frame: 4 minutes
Ohio State University TBI Identification Method
Time frame: 8 minutes
Automated Neuropsychological Assessment Metric
Time frame: 30 minutes
Vestibular Ocular Motor Screening
Time frame: 15 minutes
Revised HiMAT
Time frame: 15 minutes
Functional Gait Assessment
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Background: PubMed 29078732Fino 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.
- Background: PubMed 23766395Scherer 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.
- Background: PubMed 28540448King 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.
- Derived from this study: PubMed 37856171Weightman MM, King LA, Fino PC, Dibble LE, Pelo R, Michielutti PG, Richard H, Parrington L, Lester ME, Hoppes CW. Reconsidering Vestibular/Ocular Motor Screening Cutoff Scores for Concussion. Mil Med. 2024 Feb 27;189(3-4):e714-e720. doi: 10.1093/milmed/usad394.
- Derived from this study: PubMed 36538333Fino 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.
- Derived from this study: PubMed 35067602Parrington 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.
- Derived from this study: PubMed 33519659Fino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie King principal investigator
Oregon Health and Science University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury and Gait, run by Oregon Health and Science University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illinois Agility Assessment (time frame: 15 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03892291, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.