- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07505537
Using BlazePod® for Pre-Season Screening of Lower Limb Injury Risk
March 26, 2026 updated by: MARIO ALEXANDRE GONÇALVES LOPES, Aveiro University
Preventing lower limb injuries is a key concern in sports and physical activities.
Even though injury prevention programs and pre-season screening have improved recently, these injuries still happen often.
New technology might help improve traditional screening methods.
The BlazePod® system offers a fresh, active way to assess function and train physical skills.
This study aims to explore the link between the BlazePod® One-Leg Balance Activity (OLBA) test and the Y-Balance Test (YBT) in healthy young adults.
Using kinematic analysis, we want to see if the OLBA test can serve as a preseason tool to predict ankle injuries.
Participants will complete the YBT, the Weight-Bearing Lunge Test, and the OLBA test with the BlazePod® system, along with the Cumberland Ankle Instability Tool (CAIT) and a sociodemographic questionnaire.
We will record all tests using the Vicon T20S 3D motion capture system and analyze the data with MOKKA software.
We expect to find a significant positive correlation between the average taps in the BlazePod® test and the combined YBT score.
These results could show that the OLBA test with BlazePod® is a useful way to assess ankle injury risk.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Prevention of lower limb injuries is a major concern in sports and physical activity.
Although injury prevention programs and pre-season screening tests have improved in recent years, the incidence of lower limb injuries remains high.
Recent technological advances may complement traditional screening methods in identifying injury risk.
The BlazePod® system offers an innovative, dynamic approach to functional assessment and physical skills training.
The main objective of this study is to examine the relationship between the BlazePod® One-Leg Balance Activity (OLBA) test and the Y-Balance Test (YBT) in healthy young adults, using kinematic analysis to determine whether the OLBA test can be used as a preseason screening tool to predict ankle injuries.
Participants will perform the YBT, the Weight-Bearing Lunge Test, and the OLBA test using the BlazePod® system and will complete the Cumberland Ankle Instability Tool (CAIT) and a sociodemographic questionnaire.
All functional tests will be recorded using the Vicon T20S 3D motion capture system and analyzed with MOKKA software.
We expect the results to show a statistically significant, positive correlation between the average number of taps in the BlazePod® test and the composite YBT score.
We expect that these findings will suggest that the OLBA test using BlazePod® may be a useful tool for assessing ankle injury risk.
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mário Lopes Professor, PhD
- Phone Number: 22155 00351234372456
- Email: mariolopes77@ua.pt
Study Locations
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Aveiro District
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Aveiro, Aveiro District, Portugal, 3810-193
- University of Aveiro
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Contact:
- Rui Costa Professor, PhD
- Phone Number: 00351967032521
- Email: rcosta@ua.pt
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Active university students of both sexes, aged ≥18 years, that practice physical activity regularly and without recent complaints in the lower limbs or spine will be recruited for the study.
Description
Inclusion Criteria:
- Individuals aged ≥18 years, practicing physical activity, and without recent complaints in the lower limbs or spine will be included.
Exclusion Criteria:
- Participants with federated sports practice, recent history of ankle sprain, surgery or musculoskeletal injury in the lower limb, as well as systemic pathologies affecting balance or neuromotor control will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Ankle Range of Motion
The weight-bearing lunge test will be executed using kinematic analysis to assess ankle range of motion.
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Dynamic Balance
The Y-Balance Test will be executed to assess dynamic balance, namely, the reach distance of the lower limb obtained in the 3 reach directions, normalised with the lower leg length of the participant.
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One Leg Balance Activity - OLBA Test
The one-leg balance activity will be executed with the Blazepod reflex training system, where the participant has to tap the pod that lights up during 60 seconds as fast as possible without losing balance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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One Leg Balance Activity with the Blazepod
Time Frame: From enrollment to the end of treatment at 1 week.
|
The One-Leg Balance Activity will be assessed using the BlazePod® system to quantify the number of taps a participant can perform within 60 seconds while maintaining balance.
During the test, pods illuminate in an alternating sequence, and participants are required to respond by tapping each light as quickly as possible without losing postural stability.
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From enrollment to the end of treatment at 1 week.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic Balance
Time Frame: From enrollment to the end of treatment at 1 week.
|
The participant will execute the Y-Balance Test to assess dynamic balance.
The composite score of the 3 reach distances will be used for analysis.
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From enrollment to the end of treatment at 1 week.
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Ankle dorsiflexion range of motion
Time Frame: From enrollment to the end of treatment at 1 week.
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The ankle dorsiflexion range of motion will be assessed with the weight-bearing lunge test with kinematic analysis.
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From enrollment to the end of treatment at 1 week.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Powden CJ, Hoch JM, Hoch MC. Reliability and minimal detectable change of the weight-bearing lunge test: A systematic review. Man Ther. 2015 Aug;20(4):524-32. doi: 10.1016/j.math.2015.01.004. Epub 2015 Jan 29.
- Plisky P, Schwartkopf-Phifer K, Huebner B, Garner MB, Bullock G. Systematic Review and Meta-Analysis of the Y-Balance Test Lower Quarter: Reliability, Discriminant Validity, and Predictive Validity. Int J Sports Phys Ther. 2021 Oct 1;16(5):1190-1209. doi: 10.26603/001c.27634. eCollection 2021.
- Flores FS, Lourenco J, Phan L, Jacobs S, Willig RM, Marconcin PEP, Casanova N, Soares D, Clemente FM, Silva AF. Evaluation of Reaction Time during the One-Leg Balance Activity in Young Soccer Players: A Pilot Study. Children (Basel). 2023 Apr 19;10(4):743. doi: 10.3390/children10040743.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 6, 2026
Primary Completion (Estimated)
April 13, 2026
Study Completion (Estimated)
April 13, 2026
Study Registration Dates
First Submitted
March 26, 2026
First Submitted That Met QC Criteria
March 26, 2026
First Posted (Actual)
April 1, 2026
Study Record Updates
Last Update Posted (Actual)
April 1, 2026
Last Update Submitted That Met QC Criteria
March 26, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AveiroU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Individual participant data (IPD) will be shared upon reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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