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Balance and Mild Traumatic Brain Injury (TBI)

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Laurie King, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01377454
First received: June 17, 2011
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

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).


Condition
Brain Concussion
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Wearable Sensor to Detect Postural Instability in People After Mild Traumatic Brain Injury (mTBI)

Resource links provided by NLM:

U.S. FDA Resources

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

Enrollment: 47
Study Start Date: June 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Detailed 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.
  Eligibility

Ages Eligible for Study:   12 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy controls or individuals with mild Traumatic Brain Injury (mTBI) or concussion.

Criteria

Inclusion Criteria:

  • Have a mild Traumatic Brain Injury or Concussion
  • Between the ages 12-40 years

Exclusion Criteria:

  • Out of age range
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377454

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Oregon Health and Science University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

No publications provided

Responsible Party: Laurie King, Assistant Professor of Neurology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01377454     History of Changes
Other Study ID Numbers: 7419
Study First Received: June 17, 2011
Last Updated: August 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
mTBI
concussion
mild Traumatic Brain Injury
balance
sensors

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

ClinicalTrials.gov processed this record on May 19, 2013