Concussion, BrainNCT05344703
Is Y-Balance Test Predictive of Concussion
A study testing Y Balance Plus Visual Perturbations and Y balance in people with Concussion, Brain and Concussion; Eye, run by Arkansas Colleges of Health Education at 2 sites in United States.
Trial summary
The Y Balance Test for the lower quarter (YBT-LQ) is a movement screen used to assess an athlete's risk for injury. The YBT-LQ is a dynamic balance test where the participant stands on a single leg and with the opposite lower extremity reaches are far in the anterior direction as they can, and this value is measured. Read more about this study
- Who is it for?
- Ages 11 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Brain, Concussion; Eye
- What is being tested?
- Y Balance Plus Visual Perturbations and Y balance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 May 2022to 31 Dec 2025
- Phase
- Interventional
- 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 11 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participates in sport either school sanctioned or club
Who cannot join
- History of seizure
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Fort Smith Public Schools
Fort Smith, Arkansas, 72916
Alex Habegger, 402-852-6509, ahabegge@gmail.com
- Recruiting
Greenwood Public Schools
Fort Smith, Arkansas, 72916
Alex Habegger, 402-852-6509, ahabegge@gmail.com
About this study
The Y Balance Test for the lower quarter (YBT-LQ) is a movement screen used to assess an athlete's risk for injury. The YBT-LQ is a dynamic balance test where the participant stands on a single leg and with the opposite lower extremity reaches are far in the anterior direction as they can, and this value is measured. The process is repeated in the posterior medial, and the posterior lateral directions. The final values are controlled for leg length of the participants. The YBT-LQ has been shown to be predictive of lower extremity injury in high school basketball players, but it is typically used as part of a battery of tests to determine the athlete's overall injury risk, but more questions remain to be answered. The research question: Is the YBT-LQ predictive of concussion in high school athletes? What are the norms for YBT-LQ in high school athletes? Does history of concussion effect YBT-LQ? Is the YBT-LQ with visual perturbations predictive of concussions? Is the YBT-LQ with visual perturbations predictive of lower extremity injury? What is the impact of visual perturbations on Y-balance and its injury prevention capability?
The target student participants will be 9th through 12th grade students; however, 6th to 8th grade students will be allowed to participate depending on the school or organization request. Informed consent will be obtained reiterating that participation is voluntary. Testing utilizing the YBT-LQ will occur, and sport of participation, age, height, weight, dorsiflexion, and leg length will be obtained. Follow up will be made via the athletic trainers and school personnel to indicate the effected athletes. Once the post-test follow up is complete athletes will be able to see their pre-test scores, and any questions will be answered at that time. This will be a longitudinal study where testing will take place at least two times per year, preferably three times per year over 4 years.
- Conditions
- Concussion, Brain, Concussion; Eye
- Being tested
- Y Balance Plus Visual Perturbations, Y balance
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y Balance Plus Visual PerturbationsDevice
Stroboscopic glasses will be added to the protocol for the participants to perform the Y-balance lower quarter to examine the differences in Y-balance scores as well as examining the Y-balance's ability to predict injury and concussion with visual perturbations.
Y balanceDiagnostic test
Subjects will perform Y-balance without any interventional strategies.
| Study group | Role | What they receive |
|---|---|---|
| Standard Y Balance | Active comparator | Subjects will perform Y-balance lower quarter Receives: Diagnostic Test: Y balance |
| Y Balance Plus Stroboscopic Glasses | Active comparator | Subjects will perform Y-balance lower quarter with and without stroboscopic lenses Receives: Device: Y Balance Plus Visual Perturbations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Report of concussion in past year
Determine if patient sustained concussion since test date utilizing this questionnaire.
Measured: 1 year
Report of lower extremity injury in past year
This will be determined utilizing intake questionnaire as developed by research team delineating joint or structure impacted by injury.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start4 May 2022 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group of 6th to 12th graders
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Colleges of Health Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Habegger, Arkansas Colleges of Health Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344703
- Sponsor's protocol ID
- ArkansasCollegesHlthEd
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Y-Balance Test Predictive of Concussion
- ClinicalTrials.gov ID
- NCT05344703
- Acronym / sponsor ID
- ArkansasCollegesHlthEd
- Conditions
- Concussion, Brain, Concussion; Eye
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Arkansas Colleges of Health EducationUniversity, hospital or other
- Study start
- 4 May 2022 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Apr 2022 (actual)
- 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 Y Balance Test for the lower quarter (YBT-LQ) is a movement screen used to assess an athlete's risk for injury. The YBT-LQ is a dynamic balance test where the participant stands on a single leg and with the opposite lower extremity reaches are far in the anterior direction as they can, and this value is measured. The process is repeated in the posterior medial, and the posterior lateral directions. The final values are controlled for leg length of the participants. The YBT-LQ has been shown to be predictive of lower extremity injury in high school basketball players, but it is typically used as part of a battery of tests to determine the athlete's overall injury risk, but more questions remain to be answered. The research question: Is the YBT-LQ predictive of concussion in high school athletes? What are the norms for YBT-LQ in high school athletes? Does history of concussion effect YBT-LQ? Is the YBT-LQ with visual perturbations predictive of concussions? Is the YBT-LQ with visual perturbations predictive of lower extremity injury? What is the impact of visual perturbations on Y-balance and its injury prevention capability?
The target student participants will be 9th through 12th grade students; however, 6th to 8th grade students will be allowed to participate depending on the school or organization request. Informed consent will be obtained reiterating that participation is voluntary. Testing utilizing the YBT-LQ will occur, and sport of participation, age, height, weight, dorsiflexion, and leg length will be obtained. Follow up will be made via the athletic trainers and school personnel to indicate the effected athletes. Once the post-test follow up is complete athletes will be able to see their pre-test scores, and any questions will be answered at that time. This will be a longitudinal study where testing will take place at least two times per year, preferably three times per year over 4 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single group of 6th to 12th graders
| Arm | Type | Receives |
|---|---|---|
| Standard Y Balance | Active comparator | Diagnostic Test: Y balanceSubjects will perform Y-balance lower quarter |
| Y Balance Plus Stroboscopic Glasses | Active comparator | Device: Y Balance Plus Visual PerturbationsSubjects will perform Y-balance lower quarter with and without stroboscopic lenses |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participates in sport either school sanctioned or club
Key exclusion criteria (1 listed)
- History of seizure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Y Balance Plus Visual PerturbationsStroboscopic glasses will be added to the protocol for the participants to perform the Y-balance lower quarter to examine the differences in Y-balance scores as well as examining the Y-balance's ability to predict injury and concussion with visual perturbations. | Device | Y Balance Plus Stroboscopic Glasses |
| Y balanceSubjects will perform Y-balance without any interventional strategies. | Diagnostic test | Standard Y Balance |
Primary outcome
Report of concussion in past year
Time frame: 1 year
Determine if patient sustained concussion since test date utilizing this questionnaire.
Report of lower extremity injury in past year
Time frame: 1 year
This will be determined utilizing intake questionnaire as developed by research team delineating joint or structure impacted by injury.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Y Balance Plus Visual Perturbations and Y balance in people with Concussion, Brain and Concussion; Eye, run by Arkansas Colleges of Health Education at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Report of concussion in past year (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2022.