Healthy SubjectsNCT07826312
Y-Balance Test Training for Ankle Function and Lower Limb Functional Performance
A study testing Y-Balance Test-Based Training Program in people with Healthy Subjects, run by Aveiro University at 1 site in Portugal.
Trial summary
This randomized controlled study investigated whether a 6-week home-based training program based on the Y-Balance Test could improve ankle function and lower limb functional performance in university students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Y-Balance Test-Based Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePortugal
- Study dates
- 16 Mar 2026to 15 May 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enrolled in an undergraduate degree at the School of Health Sciences, University of Aveiro.
- Aged 18 years or older.
- Able and willing to provide written informed consent.
Who cannot join
- Current pain, injury, or medical condition that prevents the safe performance of the study assessments, based on self-report during the baseline assessment.
- Unable to comply with the intervention protocol or the assessment sessions.
- Not willing to agree to the terms of the informed consent.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Escola Superior de Saúde da Universidade de Aveiro
Aveiro, Aveiro District, 3810-193
About this study
Official title: Effect of a Y-Balance Test-Based Training Protocol on Ankle Function and Lower Limb Injury Prevention
This randomized controlled study investigated whether a 6-week home-based training program based on the Y-Balance Test could improve ankle function and lower limb functional performance in university students. The Y-Balance Test is a functional task that involves standing on one leg while reaching in different directions with the other leg, and it is commonly used to assess dynamic balance and postural control.
Participants were randomly assigned to either an experimental group, which performed the Y-Balance Test-based training program, or a control group, which maintained its usual routine without intervention. All participants were assessed at baseline and after 6 weeks.
Read more
The study assessed Y-Balance Test performance, weight-bearing ankle dorsiflexion, ankle maximal isometric strength, and self-reported ankle function. These outcomes were selected because they are relevant components of ankle function and lower limb performance.
The main goal of the study was to determine whether this structured training program led to greater improvements in Y-Balance Test composite score than no intervention. Secondary aims included assessing changes in normalized reach distances, ankle dorsiflexion, ankle strength, and self-reported ankle function. The study did not directly assess injury incidence, but focused on functional measures commonly used in the assessment of factors related to lower limb injury risk.
- Conditions
- Healthy Subjects
- Being tested
- Y-Balance Test-Based Training Program
- Keywords
- Y-Balance Test, Ankle Strength, Ankle Function, Exercise Training, Lower Limb Injury Risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-Balance Test-Based Training ProgramBehavioural
Participants completed a 6-week home-based training program based on the Y-Balance Test, performed 5 times per week, for a total planned dose of 30 sessions. The program used a paper Y-Balance Test kit provided to participants. In each session, participants performed six maximal attempts per lower limb, reaching in the anterior, posteromedial, and posterolateral directions. Rest between attempts was self-managed. The program was self-administered, with initial face-to-face instructions and access to online demonstration videos.
| Study group | Role | What they receive |
|---|---|---|
| Y-Balance Test-Based Training | Experimental | Participants in this arm completed a 6-week home-based Y-Balance Test-based training program, performed 5 times per week. Outcome measures were assessed at baseline and after 6 weeks. Receives: Behavioral: Y-Balance Test-Based Training Program |
| No Additional Training Control | No intervention | Participants in this arm did not receive any intervention and maintained their usual routine during the study period. Outcome measures were assessed at baseline and after 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Dominant Lower Limb Y-Balance Test Composite Score at 6 Weeks
Composite score (%) of the dominant lower limb calculated from the maximal reach distances in the anterior, posteromedial, and posterolateral directions of the Y-Balance Test, normalized to lower limb length using the formula: [(anterior + posteromedial + posterolateral) / (3 × lower limb length)] × 100. Higher values indicate better performance on the test.
Measured: Baseline and 6 weeks
Change from Baseline in Non Dominant Lower Limb Y-Balance Test Composite Score at 6 Weeks
Composite score (%) of the non dominant lower limb calculated from the maximal reach distances in the anterior, posteromedial, and posterolateral directions of the Y-Balance Test, normalized to lower limb length using the formula: [(anterior + posteromedial + posterolateral) / (3 × lower limb length)] × 100. Higher values indicate better performance on the test.
Measured: Baseline and 6 weeks
Secondary outcomes (18)
Change from Baseline in Dominant Ankle Weight-Bearing Dorsiflexion at 6 Weeks
Weight-bearing ankle dorsiflexion measured using the Knee-to-Wall Test. The distance between the great toe and the wall was recorded in centimeters at the maximal position in which the participant could touch the knee to the wall while maintaining the heel in contact with the floor. The mean of three trials was used. Higher values indicate greater weight-bearing dorsiflexion.
Measured: Baseline and 6 weeks
Change from Baseline in Non Dominant Ankle Weight-Bearing Dorsiflexion at 6 Weeks
Weight-bearing ankle dorsiflexion measured using the Knee-to-Wall Test. The distance between the great toe and the wall was recorded in centimeters at the maximal position in which the participant could touch the knee to the wall while maintaining the heel in contact with the floor. The mean of three trials was used. Higher values indicate greater weight-bearing dorsiflexion.
Measured: Baseline and 6 weeks
Change from Baseline in Dominant Ankle Inversion Maximal Isometric Strength at 6 Weeks
Maximal isometric strength of Dominant ankle inversion measured using a microFET2 handheld dynamometer during a standardized make test. Three maximal 5-second contractions were performed, and the highest peak force was used for analysis. Results are expressed in kilogram-force (kgf), with higher values indicating greater maximal isometric strength.
Measured: baseline and 6 weeks
Change from Baseline in Non Dominant Ankle Inversion Maximal Isometric Strength at 6 Weeks
Maximal isometric strength of Non Dominant ankle inversion measured using a microFET2 handheld dynamometer during a standardized make test. Three maximal 5-second contractions were performed, and the highest peak force was used for analysis. Results are expressed in kilogram-force (kgf), with higher values indicating greater maximal isometric strength.
Measured: Baseline and 6 weeks
Change from Baseline in Dominant Ankle Eversion Maximal Isometric Strength at 6 Weeks
Maximal isometric strength of Dominant ankle eversion measured using a microFET2 handheld dynamometer during a standardized make test. Three maximal 5-second contractions were performed, and the highest peak force was used for analysis. Results are expressed in kilogram-force (kgf), with higher values indicating greater maximal isometric strength.
Measured: Baseline and 6 weeks
Change from Baseline in Non Dominant Ankle Eversion Maximal Isometric Strength at 6 Weeks
Maximal isometric strength of non Dominant ankle eversion measured using a microFET2 handheld dynamometer during a standardized make test. Three maximal 5-second contractions were performed, and the highest peak force was used for analysis. Results are expressed in kilogram-force (kgf), with higher values indicating greater maximal isometric strength.
Measured: Baseline and 6 weeks
Change from Baseline in Dominant Ankle Dorsiflexion Maximal Isometric Strength at 6 Weeks
Maximal isometric strength of Dominant ankle dorsiflexion measured using a microFET2 handheld dynamometer during a standardized make test. Three maximal 5-second contractions were performed, and the highest peak force was used for analysis. Results are expressed in kilogram-force (kgf), with higher values indicating greater maximal isometric strength.
Measured: baseline and 6 weeks
Change from Baseline in Non Dominant Ankle Dorsiflexion Maximal Isometric Strength at 6 Weeks
Maximal isometric strength of Non Dominant ankle dorsiflexion measured using a microFET2 handheld dynamometer during a standardized make test. Three maximal 5-second contractions were performed, and the highest peak force was used for analysis. Results are expressed in kilogram-force (kgf), with higher values indicating greater maximal isometric strength.
Measured: Baseline and 6 weeks
Change from Baseline in Dominant Ankle Plantar Flexion Maximal Isometric Strength at 6 Weeks
Maximal isometric strength of Dominant ankle plantar flexion measured using a microFET2 handheld dynamometer during a standardized make test. Three maximal 5-second contractions were performed, and the highest peak force was used for analysis. Results are expressed in kilogram-force (kgf), with higher values indicating greater maximal isometric strength.
Measured: Baseline and 6 weeks
Change from Baseline in Non Dominant Ankle Plantar Flexion Maximal Isometric Strength at 6 Weeks
Maximal isometric strength of Non Dominant ankle plantar flexion measured using a microFET2 handheld dynamometer during a standardized make test. Three maximal 5-second contractions were performed, and the highest peak force was used for analysis. Results are expressed in kilogram-force (kgf), with higher values indicating greater maximal isometric strength.
Measured: Baseline and 6 weeks
Change from Baseline in Dominant Ankle Self-Reported Function Assessed by the Portuguese Cumberland Ankle Instability Tool at 6 Weeks
Self-reported Dominant ankle function and perceived instability assessed using the Portuguese version of the Cumberland Ankle Instability Tool. The questionnaire contains nine items and is scored separately for each ankle. The total score ranges from 0 to 30, with higher scores indicating better self-reported ankle function and less perceived instability.
Measured: Baseline and 6 weeks
Change from Baseline in Non Dominant Ankle Self-Reported Function Assessed by the Portuguese Cumberland Ankle Instability Tool at 6 Weeks
Self-reported Non Dominant ankle function and perceived instability assessed using the Portuguese version of the Cumberland Ankle Instability Tool. The questionnaire contains nine items and is scored separately for each ankle. The total score ranges from 0 to 30, with higher scores indicating better self-reported ankle function and less perceived instability.
Measured: Baseline and 6 weeks
Change from Baseline in Dominant Lower Limb Y-Balance Test Anterior Reach Distance at 6 Weeks
Normalized reach distance (%) in the specified Y-Balance Test direction, calculated as maximal reach distance divided by lower limb length and multiplied by 100. Higher values indicate better reach performance in that direction.
Measured: Baseline and 6 weeks
Change from Baseline in Non-Dominant Lower Limb Y-Balance Test Anterior Reach Distance at 6 Weeks
Normalized reach distance (%) in the specified Y-Balance Test direction, calculated as maximal reach distance divided by lower limb length and multiplied by 100. Higher values indicate better reach performance in that direction.
Measured: Baseline and 6 weeks
Change from Baseline in Dominant Lower Limb Y-Balance Test Posteromedial Reach Distance at 6 Weeks
Normalized reach distance (%) in the specified Y-Balance Test direction, calculated as maximal reach distance divided by lower limb length and multiplied by 100. Higher values indicate better reach performance in that direction.
Measured: Baseline and 6 weeks
Change from Baseline in Non-Dominant Lower Limb Y-Balance Test Posteromedial Reach Distance at 6 Weeks
Normalized reach distance (%) in the specified Y-Balance Test direction, calculated as maximal reach distance divided by lower limb length and multiplied by 100. Higher values indicate better reach performance in that direction.
Measured: Baseline and 6 weeks
Change from Baseline in Dominant Lower Limb Y-Balance Test Posterolateral Reach Distance at 6 Weeks
Normalized reach distance (%) in the specified Y-Balance Test direction, calculated as maximal reach distance divided by lower limb length and multiplied by 100. Higher values indicate better reach performance in that direction.
Measured: Baseline and 6 weeks
Change from Baseline in Non-Dominant Lower Limb Y-Balance Test Posterolateral Reach Distance at 6 Weeks
Normalized reach distance (%) in the specified Y-Balance Test direction, calculated as maximal reach distance divided by lower limb length and multiplied by 100. Higher values indicate better reach performance in that direction.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start16 Mar 2026
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel groups using a sex-stratified block randomization procedure. The experimental group completed a 6-week Y-Balance Test-based home training program, while the control group maintained its usual routine without intervention. Assessments were conducted at baseline and after 6 weeks.
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIO ALEXANDRE GONÇALVES LOPES, Aveiro University
- Investigators
- Mário A Lopes, PhD, Principal investigator, Escola Superior de Saúde da Universidade de Aveiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826312
- Sponsor's protocol ID
- 11-CEIC-UA/2026-M
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Y-Balance Test-Based Training Protocol on Ankle Function and Lower Limb Injury Prevention
- ClinicalTrials.gov ID
- NCT07826312
- Acronym / sponsor ID
- 11-CEIC-UA/2026-M
- Conditions
- Healthy Subjects
- Keywords
- Y-Balance Test, Ankle Strength, Ankle Function, Exercise Training, Lower Limb Injury Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 17 Sep 2026 (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.
This randomized controlled study investigated whether a 6-week home-based training program based on the Y-Balance Test could improve ankle function and lower limb functional performance in university students. The Y-Balance Test is a functional task that involves standing on one leg while reaching in different directions with the other leg, and it is commonly used to assess dynamic balance and postural control.
Participants were randomly assigned to either an experimental group, which performed the Y-Balance Test-based training program, or a control group, which maintained its usual routine without intervention. All participants were assessed at baseline and after 6 weeks.
The study assessed Y-Balance Test performance, weight-bearing ankle dorsiflexion, ankle maximal isometric strength, and self-reported ankle function. These outcomes were selected because they are relevant components of ankle function and lower limb performance.
The main goal of the study was to determine whether this structured training program led to greater improvements in Y-Balance Test composite score than no intervention. Secondary aims included assessing changes in normalized reach distances, ankle dorsiflexion, ankle strength, and self-reported ankle function. The study did not directly assess injury incidence, but focused on functional measures commonly used in the assessment of factors related to lower limb injury risk.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel groups using a sex-stratified block randomization procedure. The experimental group completed a 6-week Y-Balance Test-based home training program, while the control group maintained its usual routine without intervention. Assessments were conducted at baseline and after 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| Y-Balance Test-Based Training | Experimental | Behavioral: Y-Balance Test-Based Training ProgramParticipants in this arm completed a 6-week home-based Y-Balance Test-based training program, performed 5 times per week. Outcome measures were assessed at baseline and after 6 weeks. |
| No Additional Training Control | No intervention | –Participants in this arm did not receive any intervention and maintained their usual routine during the study period. Outcome measures were assessed at baseline and after 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Enrolled in an undergraduate degree at the School of Health Sciences, University of Aveiro.
- Aged 18 years or older.
- Able and willing to provide written informed consent.
Key exclusion criteria (3 listed)
- Current pain, injury, or medical condition that prevents the safe performance of the study assessments, based on self-report during the baseline assessment.
- Unable to comply with the intervention protocol or the assessment sessions.
- Not willing to agree to the terms of the informed consent.
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 Test-Based Training ProgramParticipants completed a 6-week home-based training program based on the Y-Balance Test, performed 5 times per week, for a total planned dose of 30 sessions. The program used a paper Y-Balance Test kit provided to participants. In each session, participants performed six maximal attempts per lower limb, reaching in the anterior, posteromedial, and posterolateral directions. Rest between attempts was self-managed. The program was self-administered, with initial face-to-face instructions and access to online demonstration videos. | Behavioural | Y-Balance Test-Based Training |
Primary outcome
Change from Baseline in Dominant Lower Limb Y-Balance Test Composite Score at 6 Weeks
Time frame: Baseline and 6 weeks
Composite score (%) of the dominant lower limb calculated from the maximal reach distances in the anterior, posteromedial, and posterolateral directions of the Y-Balance Test, normalized to lower limb length using the formula: [(anterior + posteromedial + posterolateral) / (3 × lower limb length)] × 100. Higher values indicate better performance on the test.
Change from Baseline in Non Dominant Lower Limb Y-Balance Test Composite Score at 6 Weeks
Time frame: Baseline and 6 weeks
Composite score (%) of the non dominant lower limb calculated from the maximal reach distances in the anterior, posteromedial, and posterolateral directions of the Y-Balance Test, normalized to lower limb length using the formula: [(anterior + posteromedial + posterolateral) / (3 × lower limb length)] × 100. Higher values indicate better performance on the test.
18 secondary outcomes
Change from Baseline in Dominant Ankle Weight-Bearing Dorsiflexion at 6 Weeks
Time frame: Baseline and 6 weeks
Change from Baseline in Non Dominant Ankle Weight-Bearing Dorsiflexion at 6 Weeks
Time frame: Baseline and 6 weeks
Change from Baseline in Dominant Ankle Inversion Maximal Isometric Strength at 6 Weeks
Time frame: baseline and 6 weeks
Change from Baseline in Non Dominant Ankle Inversion Maximal Isometric Strength at 6 Weeks
Time frame: Baseline and 6 weeks
Change from Baseline in Dominant Ankle Eversion Maximal Isometric Strength at 6 Weeks
Time frame: Baseline and 6 weeks
Change from Baseline in Non Dominant Ankle Eversion Maximal Isometric Strength at 6 Weeks
Time frame: Baseline and 6 weeks
Change from Baseline in Dominant Ankle Dorsiflexion Maximal Isometric Strength at 6 Weeks
Time frame: baseline and 6 weeks
Change from Baseline in Non Dominant Ankle Dorsiflexion Maximal Isometric Strength at 6 Weeks
Time frame: Baseline and 6 weeks
Change from Baseline in Dominant Ankle Plantar Flexion Maximal Isometric Strength at 6 Weeks
Time frame: Baseline and 6 weeks
Change from Baseline in Non Dominant Ankle Plantar Flexion Maximal Isometric Strength at 6 Weeks
Time frame: Baseline and 6 weeks
Change from Baseline in Dominant Ankle Self-Reported Function Assessed by the Portuguese Cumberland Ankle Instability Tool at 6 Weeks
Time frame: Baseline and 6 weeks
Change from Baseline in Non Dominant Ankle Self-Reported Function Assessed by the Portuguese Cumberland Ankle Instability Tool at 6 Weeks
Time frame: Baseline and 6 weeks
Change from Baseline in Dominant Lower Limb Y-Balance Test Anterior Reach Distance at 6 Weeks
Time frame: Baseline and 6 weeks
Change from Baseline in Non-Dominant Lower Limb Y-Balance Test Anterior Reach Distance at 6 Weeks
Time frame: Baseline and 6 weeks
Change from Baseline in Dominant Lower Limb Y-Balance Test Posteromedial Reach Distance at 6 Weeks
Time frame: Baseline and 6 weeks
Change from Baseline in Non-Dominant Lower Limb Y-Balance Test Posteromedial Reach Distance at 6 Weeks
Time frame: Baseline and 6 weeks
Change from Baseline in Dominant Lower Limb Y-Balance Test Posterolateral Reach Distance at 6 Weeks
Time frame: Baseline and 6 weeks
Change from Baseline in Non-Dominant Lower Limb Y-Balance Test Posterolateral Reach Distance at 6 Weeks
Time frame: Baseline and 6 weeks
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 22 Sep 2026.
- 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.
Mário A Lopes, PhD principal investigator
Escola Superior de Saúde da Universidade de Aveiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Y-Balance Test-Based Training Program in people with Healthy Subjects, run by Aveiro University at 1 site in Portugal.
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 3 inclusion and 3 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 22 Sep 2026. 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 Portugal. 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.
What does the primary outcome measure?
Change from Baseline in Dominant Lower Limb Y-Balance Test Composite Score at 6 Weeks (time frame: Baseline and 6 weeks). 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 22 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.