Balance and Mild Traumatic Brain Injury (TBI)

Traumatic Brain Injury Clinical Trial

Official title:

Wearable Sensor to Detect Postural Instability in People After Mild Traumatic Brain Injury (mTBI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377454
• Other study ID #: 7419
• Status: Completed
• Phase: N/A
• First received: June 17, 2011
• Last updated: August 7, 2012
• Start date: June 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this pilot project is to determine whether using one inertial sensor 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).

Description:

The purpose of this pilot project is to gather preliminary data to determine whether using one inertial sensor at the waist during the BESS could provide the examiner with a more immediate, objective, reliable and sensitive way to quantify deficits in postural control in the post-concussive population. The investigators hypothesize that the metrics obtained from the iSWAY will be better able to distinguish mTBI subjects from control subjects than the standard clinical assessment. The specific aims are:

1. To determine test-retest and inter-rater reliability of the clinical BESS compared to the instrumented BESS test.

2. To determine if an instrumented BESS can distinguish mTBI from age-matched control subjects better than the commonly used BESS and to determine the best metrics of sway to separate groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 40 Years

Eligibility

Inclusion Criteria:

• Have a mild Traumatic Brain Injury or Concussion

• Between the ages 12-40 years

Exclusion Criteria:

• Out of age range

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States,