NCT07238270

Brief Summary

This study aims to explore the relationship between children's physical fitness and flatfoot. Specifically, it is designed to determine whether fitness levels are linked to the incidence and severity of flatfoot and to explore other possible factors, including genetics, exercise behavior, and body weight.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
Last Updated

November 20, 2025

Status Verified

August 1, 2025

Enrollment Period

2.1 years

First QC Date

August 29, 2025

Last Update Submit

November 18, 2025

Conditions

Flatfoot

Keywords

physical fitnessflatfoot

Outcome Measures

Primary Outcomes (10)

  • Questionnaire Score

    Score from a self-designed questionnaire on lifestyle habits and foot-related symptoms. Scale range: higher scores = better habits, fewer symptoms.

    Baseline

  • Body Fat Percentage

    Body fat percentage measured using InBody analyzer. Unit: Percent (%) (lower values indicate better body composition).

    Baseline

  • Skeletal Muscle Mass

    Skeletal muscle mass measured using InBody analyzer. Unit: Kilograms (higher values indicate greater muscle mass).

    Baseline

  • Cardiorespiratory Endurance

    Performance on standardized shuttle run test. Unit: Seconds (shorter time indicates better endurance).

    Baseline

  • Handgrip Strength

    Grip strength measured using digital dynamometer. Unit: Kilograms (higher values indicate greater strength).

    Baseline

  • Pinch Strength

    Pinch force measured with a pinch gauge. Unit: Kilograms (higher values indicate greater strength).

    Baseline

  • Flexibility Test

    Sit and reach distance measured in centimeters. Unit: Centimeters (higher values indicate greater flexibility).

    Baseline

  • Balance Ability

    Time maintaining one-leg stance without support. Unit: Seconds (longer time indicates better balance).

    Baseline

  • Arch Index

    Foot arch index derived from footprint analysis. Unit: Ratio (0.2-0.3 indicates normal arch).

    Baseline

  • Achilles Tendon Alignment

    Deviation angle of Achilles tendon alignment. Unit: Degrees (smaller angles indicate better alignment).

    Baseline

Study Arms (4)

preschool students

Children aged about 1-6 years from northern Taiwan.

Other: No intervention (observational study)

primary school students

Children aged about 7-12 years from northern Taiwan.

Other: No intervention (observational study)

middle school students

Children aged about 13-15 years from northern Taiwan.

Other: No intervention (observational study)

high school students

Adolescents aged about 16-18 years from northern Taiwan.

Other: No intervention (observational study)

Interventions

No intervention (observational study)OTHER

This is an observational study with no intervention.

high school studentsmiddle school studentspreschool studentsprimary school students

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

600 children aged 1-18 years from northern Taiwan

You may qualify if:

  • Children aged 1-18 years

You may not qualify if:

  • Diagnosed with developmental delays
  • Diagnosed with neurological disorders
  • Presence of other congenital or acquired conditions causing impairments
  • Holders of a disability certificate
  • History of asthma
  • History of heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA

MeSH Terms

Conditions

Flatfoot

Interventions

Observation

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Chia-Ling Chen, MD, PhD

    Chang Gung Memorial Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2025

First Posted

November 20, 2025

Study Start

May 1, 2024

Primary Completion

May 31, 2026

Study Completion

May 31, 2026

Last Updated

November 20, 2025

Record last verified: 2025-08

Locations

TW(1)