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Quantification of Balance in Acutely Concussed Athletes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Laurie King, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01661075
First received: August 7, 2012
Last updated: September 26, 2016
Last verified: September 2016
  Purpose

The purpose of this pilot project is to determine whether using inertial sensors placed on the waist during routine clinical balance testing (i.e. Balance Error Scoring System) (BESS), will be a more immediate, objective, reliable and sensitive way to measure and quantify balance deficits in individuals with mild Traumatic Brain Injury (mTBI). The investigators are also trying to observe if the sensors can be used to detect balance recovery after a mTBI.

The investigators hypothesis is that collegiate atheltes with mTBI injury will have different recovery periods between their cognitive testing(IMPACT) and their balance measures.


Condition
mTBI
Concussion
Mild Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Quantification of Balance in Acutely Concussed Athletes, Implications for Return to Play Determination

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Instrumented Modified Balance Error Scoring System [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: June 2017
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
mTBI
These individuals will have had an mTBI during their respective collegiate athletic season.
healthy controls
Recruitment of healthy controls who have not suffered an mTBI for balancing testing.

Detailed Description:

The purpose of this pilot project is to determine whether using inertial sensors (ipod like device) placed on the waist during routine clinical balance testing (i.e. Balance Error Scoring System (BESS), will be a more immediate, objective, reliable and sensitive way to measure and quantify balance deficits in individuals with mild Traumatic Brain Injury (mTBI). The investigators are also trying to observe if the sensors can be used to detect balance recovery after a mTBI.

The participants will be recruited through the local university's athletic department.

The participants will undergo balance tests from the BESS test while wearing a sensor around their waist.The BESS consists of different balance tests; such as balancing on one leg and tandem standing. The participants will also answer questionnaires about their daily lives and cognitive tests. If the participant has had a mTBI they will complete questionnaires about symptoms from their injury and may perform an additional IMPACT test which is a computerized cognitive tests used by coaches, athletic trainers and managing physicians.

Along with the clinical balance tests and questionnaires, the project will use a small sensor placed on the waist to detect sway during quiet stance. An automatic analysis will occur which will provide us with immediate feedback on how stable the participant is during testing.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Collegiate atheltes
Criteria

Inclusion Criteria:

  • Collegiate athlete

Exclusion Criteria:

  • Not a current collegiate athlete,
  • recent orthopedic surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01661075

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Laurie A King, PhD Oregon Health and Science University
  More Information

Responsible Party: Laurie King, Assistant Profressor of Neurology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01661075     History of Changes
Other Study ID Numbers: 7419_2 
Study First Received: August 7, 2012
Last Updated: September 26, 2016
Health Authority: Oregon Health and Science University: USA

Keywords provided by Oregon Health and Science University:
mTBI
concussion
mild traumatic brain injury
athlete
college
football
soccer

Additional relevant MeSH terms:
Brain Injuries
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on September 30, 2016