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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Mário Lopes Professor, PhD
  • Phone Number: 22155 00351234372456
  • Email: mariolopes77@ua.pt

Study Locations

  • Portugal
    • Aveiro District
      • Aveiro, Aveiro District, Portugal, 3810-193
        • University of Aveiro
        • Contact:
          • Rui Costa Professor, PhD
          • Phone Number: 00351967032521
          • Email: rcosta@ua.pt

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Ankle Range of Motion
The weight-bearing lunge test will be executed using kinematic analysis to assess ankle range of motion.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 1 week.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
From enrollment to the end of treatment at 1 week.
Ankle dorsiflexion range of motion
Time Frame: From enrollment to the end of treatment at 1 week.
The ankle dorsiflexion range of motion will be assessed with the weight-bearing lunge test with kinematic analysis.
From enrollment to the end of treatment at 1 week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aveiro University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 13, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 13, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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