NCT01661075

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2017

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

3.8 years

First QC Date

August 7, 2012

Last Update Submit

October 6, 2017

Conditions

Keywords

mTBIconcussionmild traumatic brain injuryathletecollegefootballsoccer

Outcome Measures

Primary Outcomes (1)

  • Instrumented Modified Balance Error Scoring System

    2 months

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Collegiate atheltes

You may qualify if:

  • Collegiate athlete

You may not qualify if:

  • Not a current collegiate athlete,
  • recent orthopedic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Laurie A King, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Profressor of Neurology

Study Record Dates

First Submitted

August 7, 2012

First Posted

August 9, 2012

Study Start

August 1, 2012

Primary Completion

June 1, 2016

Study Completion

September 28, 2017

Last Updated

October 9, 2017

Record last verified: 2017-10

Locations