Overview

This trial is active, not recruiting.

Conditions mtbi, concussion, mild traumatic brain injury
Sponsor Oregon Health and Science University
Collaborator National Center for Research Resources (NCRR)
Start date August 2012
End date June 2016
Trial size 50 participants
Trial identifier NCT01661075, 7419_2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model ecologic or community
Time perspective prospective
Arm
These individuals will have had an mTBI during their respective collegiate athletic season.
Recruitment of healthy controls who have not suffered an mTBI for balancing testing.

Primary Outcomes

Measure
Instrumented Modified Balance Error Scoring System
time frame: 2 months

Eligibility Criteria

Male or female participants from 18 years up to 30 years old.

Inclusion Criteria: - Collegiate athlete Exclusion Criteria: - Not a current collegiate athlete, - recent orthopedic surgery

Additional Information

Official title Quantification of Balance in Acutely Concussed Athletes, Implications for Return to Play Determination
Principal investigator Laurie A King, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.