Brain ConcussionNCT01377454
Balance and Mild Traumatic Brain Injury (TBI)
An observational study of Brain Concussion and Traumatic Brain Injury, run by Oregon Health and Science University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion, Traumatic Brain Injury
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy controls or individuals with mild Traumatic Brain Injury (mTBI) or concussion.
Who may be able to join
- Have a mild Traumatic Brain Injury or Concussion
- Between the ages 12-40 years
Who cannot join
- Out of age range
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97201
About this study
Official title: Wearable Sensor to Detect Postural Instability in People After Mild Traumatic Brain Injury (mTBI)
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).
Read the 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:
- To determine test-retest and inter-rater reliability of the clinical BESS compared to the instrumented BESS test.
- 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.
- Conditions
- Brain Concussion, Traumatic Brain Injury
- Keywords
- mTBI, concussion, mild Traumatic Brain Injury, balance, sensors
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Laurie King, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377454
- Sponsor's protocol ID
- 7419
- Status last verified
- Aug 2012
- First submitted
- 17 Jun 2011
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
King LA, Horak FB, Mancini M, Pierce D, Priest KC, Chesnutt J, Sullivan P, Chapman JC. Instrumenting the balance error scoring system for use with patients reporting persistent balance problems after mild traumatic brain injury. Arch Phys Med Rehabil. 2014 Feb;95(2):353-9. doi: 10.1016/j.apmr.2013.10.015. Epub 2013 Nov 5.
PubMed 24200875
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Sensor to Detect Postural Instability in People After Mild Traumatic Brain Injury (mTBI)
- ClinicalTrials.gov ID
- NCT01377454
- Acronym / sponsor ID
- 7419
- Conditions
- Brain Concussion, Traumatic Brain Injury
- Keywords
- mTBI, concussion, mild Traumatic Brain Injury, balance, sensors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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:
- To determine test-retest and inter-rater reliability of the clinical BESS compared to the instrumented BESS test.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy controls or individuals with mild Traumatic Brain Injury (mTBI) or concussion.
Key inclusion criteria (2 listed)
- Have a mild Traumatic Brain Injury or Concussion
- Between the ages 12-40 years
Key exclusion criteria (1 listed)
- Out of age range
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
- Derived from this study: PubMed 24200875King LA, Horak FB, Mancini M, Pierce D, Priest KC, Chesnutt J, Sullivan P, Chapman JC. Instrumenting the balance error scoring system for use with patients reporting persistent balance problems after mild traumatic brain injury. Arch Phys Med Rehabil. 2014 Feb;95(2):353-9. doi: 10.1016/j.apmr.2013.10.015. Epub 2013 Nov 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Concussion and Traumatic Brain Injury, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01377454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2012.