- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Aveiro District
-
Aveiro, Aveiro District, Portugal, 3810-193
- Escola Superior de Saúde da Universidade de Aveiro
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
|
|
Ingen indgriben: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in Dominant Lower Limb Y-Balance Test Composite Score at 6 Weeks
Tidsramme: 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.
|
Baseline and 6 weeks
|
|
Change from Baseline in Non Dominant Lower Limb Y-Balance Test Composite Score at 6 Weeks
Tidsramme: 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.
|
Baseline and 6 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in Dominant Ankle Weight-Bearing Dorsiflexion at 6 Weeks
Tidsramme: Baseline and 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.
|
Baseline and 6 weeks
|
|
Change from Baseline in Non Dominant Ankle Weight-Bearing Dorsiflexion at 6 Weeks
Tidsramme: Baseline and 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.
|
Baseline and 6 weeks
|
|
Change from Baseline in Dominant Ankle Inversion Maximal Isometric Strength at 6 Weeks
Tidsramme: baseline and 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.
|
baseline and 6 weeks
|
|
Change from Baseline in Non Dominant Ankle Inversion Maximal Isometric Strength at 6 Weeks
Tidsramme: Baseline and 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.
|
Baseline and 6 weeks
|
|
Change from Baseline in Dominant Ankle Eversion Maximal Isometric Strength at 6 Weeks
Tidsramme: Baseline and 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.
|
Baseline and 6 weeks
|
|
Change from Baseline in Non Dominant Ankle Eversion Maximal Isometric Strength at 6 Weeks
Tidsramme: Baseline and 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.
|
Baseline and 6 weeks
|
|
Change from Baseline in Dominant Ankle Dorsiflexion Maximal Isometric Strength at 6 Weeks
Tidsramme: baseline and 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.
|
baseline and 6 weeks
|
|
Change from Baseline in Non Dominant Ankle Dorsiflexion Maximal Isometric Strength at 6 Weeks
Tidsramme: Baseline and 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.
|
Baseline and 6 weeks
|
|
Change from Baseline in Dominant Ankle Plantar Flexion Maximal Isometric Strength at 6 Weeks
Tidsramme: Baseline and 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.
|
Baseline and 6 weeks
|
|
Change from Baseline in Non Dominant Ankle Plantar Flexion Maximal Isometric Strength at 6 Weeks
Tidsramme: Baseline and 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.
|
Baseline and 6 weeks
|
|
Change from Baseline in Dominant Ankle Self-Reported Function Assessed by the Portuguese Cumberland Ankle Instability Tool at 6 Weeks
Tidsramme: Baseline and 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.
|
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
Tidsramme: Baseline and 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.
|
Baseline and 6 weeks
|
|
Change from Baseline in Dominant Lower Limb Y-Balance Test Anterior Reach Distance at 6 Weeks
Tidsramme: Baseline and 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.
|
Baseline and 6 weeks
|
|
Change from Baseline in Non-Dominant Lower Limb Y-Balance Test Anterior Reach Distance at 6 Weeks
Tidsramme: Baseline and 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.
|
Baseline and 6 weeks
|
|
Change from Baseline in Dominant Lower Limb Y-Balance Test Posteromedial Reach Distance at 6 Weeks
Tidsramme: Baseline and 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.
|
Baseline and 6 weeks
|
|
Change from Baseline in Non-Dominant Lower Limb Y-Balance Test Posteromedial Reach Distance at 6 Weeks
Tidsramme: Baseline and 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.
|
Baseline and 6 weeks
|
|
Change from Baseline in Dominant Lower Limb Y-Balance Test Posterolateral Reach Distance at 6 Weeks
Tidsramme: Baseline and 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.
|
Baseline and 6 weeks
|
|
Change from Baseline in Non-Dominant Lower Limb Y-Balance Test Posterolateral Reach Distance at 6 Weeks
Tidsramme: Baseline and 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.
|
Baseline and 6 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in Inter-Limb Asymmetry in the Y-Balance Test Composite Score at 6 Weeks
Tidsramme: Baseline and 6 weeks
|
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.
|
Baseline and 6 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Mário A Lopes, PhD, Escola Superior de Saúde da Universidade de Aveiro
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 11-CEIC-UA/2026-M
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .