NCT07826312

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 13, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

Y-Balance TestAnkle StrengthAnkle FunctionExercise TrainingLower Limb Injury Risk

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and 6 weeks

Secondary Outcomes (18)

  • Change from Baseline in Dominant Ankle Weight-Bearing Dorsiflexion at 6 Weeks

    Baseline and 6 weeks

  • Change from Baseline in Non Dominant Ankle Weight-Bearing Dorsiflexion at 6 Weeks

    Baseline and 6 weeks

  • Change from Baseline in Dominant Ankle Inversion Maximal Isometric Strength at 6 Weeks

    baseline and 6 weeks

  • Change from Baseline in Non Dominant Ankle Inversion Maximal Isometric Strength at 6 Weeks

    Baseline and 6 weeks

  • Change from Baseline in Dominant Ankle Eversion Maximal Isometric Strength at 6 Weeks

    Baseline and 6 weeks

  • +13 more secondary outcomes

Other Outcomes (1)

  • Change from Baseline in Inter-Limb Asymmetry in the Y-Balance Test Composite Score at 6 Weeks

    Baseline and 6 weeks

Study Arms (2)

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.

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.

Interventions

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.

Y-Balance Test-Based Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Saúde da Universidade de Aveiro

Aveiro, Aveiro District, 3810-193, Portugal

Location

Study Officials

  • Mário A Lopes, PhD

    Escola Superior de Saúde da Universidade de Aveiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2026

First Posted

September 17, 2026

Study Start

March 16, 2026

Primary Completion

May 15, 2026

Study Completion

May 15, 2026

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations