Clinical trial NCT01661075: Quantification of Balance in Acutely Concussed Athletes
Official title: Quantification of Balance in Acutely Concussed Athletes, Implications for Return to Play Determination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: mTBI
Concussion
Mild Traumatic Brain Injury
Keywords: mTBI
concussion
mild traumatic brain injury
athlete
college
football
soccer
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2012-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Collegiate atheltes

Brief summary: 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.

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 criteria: Inclusion Criteria:

* Collegiate athlete

Exclusion Criteria:

* Not a current collegiate athlete,
* recent orthopedic surgery

Primary outcomes:
measure: Instrumented Modified Balance Error Scoring System
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Laurie A King, PhD
role: PRINCIPAL_INVESTIGATOR
References: