Recruiting

Observational Study

Sponsor:

Clea Tucker

Code:

NCT04874389

Conditions

Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Multimodal Assessment

Study Details

Brief summary:

This study aims to explore possible solutions needed for valid and reliable multidimensional objective assessment tools to use in screening performers for concussions, as well as, for use postinjury assessment and management of the mild traumatic brain injury, regardless of time since injury occurrence. These mobile tools would also enable clinicians to test the effectiveness of the interventions used post-concussion, prior to fully releasing the performer back into full performance/active status.

Conditions

Mild Traumatic Brain Injury

Study ID

NCT04874389

Start date

May, 2021

Status verified date

May, 2021

Completion date

Aug, 2021

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Recreationally healthy and active or considered an athletic performer, males and females, to regularly engage in >150 min/week of physical activity.
  • Participants considered an athletic performer if they have history of participating in athletics at the university, amateur, elite or professional level, or are a military veteran.
  • Healthy participants defined as not currently injured, or recovering from an injury within the past 12 months, or undergone surgery within the last 12 months, or with any known history of moderate to severe traumatic brain injury resulting in impaired judgement or inability to make sound decisions within the last 12 months.
  • Post concussion participants are eligible if their last concussive event occurred within a month and up to 5 years of the date of data collection.

Exclusion Criteria:

  • If younger than 18 or >50 years of age.
  • Current cardiovascular, metabolic, psychiatric, or neurologic disease or cognitive or substance-abuse problems or taking medications that may impair cognition, balance, or functional mobility such as gait.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Recreationally active males and females

Subjects to be considered recreationally must regularly engage in >150 min/wk of physical activity (e.g., resistance training, sport or activity specific exercise, group exercise, or aerobic exercise). Healthy participants, defined as not currently injured, or recovering from an injury within the past 12 months, or undergone surgery within the last 12 months, or with any known history of moderate to severe traumatic brain injury resulting in impaired judgment or inability to make sound decisions or mild traumatic brain injury (mTBI, also commonly named "concussion") within the last 12 months.

Athletes or performing artists with reported history of concussion

Participants will be considered if they are recreationally active or considered an athletic performer (i.e.,history of participation in athletics at the university, amateur, elite or professional levels, or a military veteran), or a performing artist (i.e., stunt actors, circus artists, dancers or acrobats) with reported history of concussion incident(s), with most recent incident occurring >1 month and less than five years from the study testing dates.

Interventions

Multimodal Assessment

Participants will complete BISQ/health questionnaire and proceed to each testing station with 15 minute rest breaks in between randomly ordered assigned stations.

Primary outcome measure

  • Proof of concept for the use of multimodal objective measures for mTBI assessment & treatment guide [ Time Frame: 3-6 months for data acquisition and data analysis ]

Central Contacts and Locations

Central contacts

Clea P Tucker, DPT

3233434641ctucker@calstatela.edu

Locations

California State University, Los Angeles

Recruiting

Los Angeles, California, United States, 90032

Contacts

Clea P Tucker, DPT

323-343-4641ctucker@calstatela.edu

More Information

Sponsor

Clea Tucker

Last update posted

May 6, 2021

Last verified

May, 2021

Keywords

  • brain oxygenation
  • functional multimodal assessment
  • dual tasking
  • traumatic brain injury
  • balance
  • gait
  • cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Clea Tucker on 2021-05-06.