- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07826312
Y-Balance Test Training for Ankle Function and Lower Limb Functional Performance
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.
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Aveiro District
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Aveiro, Aveiro District, Le Portugal, 3810-193
- Escola Superior de Saúde da Universidade de Aveiro
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Y-Balance Test-Based Training
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.
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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.
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Aucune intervention: No Additional Training Control
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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from Baseline in Dominant Lower Limb Y-Balance Test Composite Score at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Non Dominant Lower Limb Y-Balance Test Composite Score at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from Baseline in Dominant Ankle Weight-Bearing Dorsiflexion at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Non Dominant Ankle Weight-Bearing Dorsiflexion at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Dominant Ankle Inversion Maximal Isometric Strength at 6 Weeks
Délai: baseline and 6 weeks
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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.
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baseline and 6 weeks
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Change from Baseline in Non Dominant Ankle Inversion Maximal Isometric Strength at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Dominant Ankle Eversion Maximal Isometric Strength at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Non Dominant Ankle Eversion Maximal Isometric Strength at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Dominant Ankle Dorsiflexion Maximal Isometric Strength at 6 Weeks
Délai: baseline and 6 weeks
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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.
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baseline and 6 weeks
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Change from Baseline in Non Dominant Ankle Dorsiflexion Maximal Isometric Strength at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Dominant Ankle Plantar Flexion Maximal Isometric Strength at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Non Dominant Ankle Plantar Flexion Maximal Isometric Strength at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Dominant Ankle Self-Reported Function Assessed by the Portuguese Cumberland Ankle Instability Tool at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Non Dominant Ankle Self-Reported Function Assessed by the Portuguese Cumberland Ankle Instability Tool at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Dominant Lower Limb Y-Balance Test Anterior Reach Distance at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Non-Dominant Lower Limb Y-Balance Test Anterior Reach Distance at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Dominant Lower Limb Y-Balance Test Posteromedial Reach Distance at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Non-Dominant Lower Limb Y-Balance Test Posteromedial Reach Distance at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Dominant Lower Limb Y-Balance Test Posterolateral Reach Distance at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Non-Dominant Lower Limb Y-Balance Test Posterolateral Reach Distance at 6 Weeks
Délai: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from Baseline in Inter-Limb Asymmetry in the Y-Balance Test Composite Score at 6 Weeks
Délai: Baseline and 6 weeks
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Inter-limb asymmetry calculated as the absolute difference between the right and left lower limb Y-Balance Test composite scores.
Results are expressed in percentage points.
Lower values indicate less asymmetry between lower limbs.
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Baseline and 6 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mário A Lopes, PhD, Escola Superior de Saúde da Universidade de Aveiro
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 11-CEIC-UA/2026-M
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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