- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07238270
Research on Physical Fitness and Flatfoot in Children
November 18, 2025 updated by: Chang Gung Memorial Hospital
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This study aims to examine the relationship between children's physical fitness and flatfoot.
We will recruit a sample of children across different ages, genders, and fitness levels.
Physical fitness will be assessed using standardized tests, including body composition, cardiorespiratory endurance, muscle strength, and flexibility.
Foot structure and function will be evaluated through arch index and plantar pressure analysis to determine the presence and severity of flatfoot.
Background information, such as age, gender, height, weight, exercise habits, and family history, will also be collected.
Study Type
Observational
Enrollment (Estimated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taoyuan District, Taiwan, 333
- Chang Gung Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
600 children aged 1-18 years from northern Taiwan
Description
Inclusion Criteria:
-Children aged 1-18 years
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
preschool students
Children aged about 1-6 years from northern Taiwan.
|
This is an observational study with no intervention.
|
|
primary school students
Children aged about 7-12 years from northern Taiwan.
|
This is an observational study with no intervention.
|
|
middle school students
Children aged about 13-15 years from northern Taiwan.
|
This is an observational study with no intervention.
|
|
high school students
Adolescents aged about 16-18 years from northern Taiwan.
|
This is an observational study with no intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questionnaire Score
Time Frame: Baseline
|
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
Time Frame: Baseline
|
Body fat percentage measured using InBody analyzer.
Unit: Percent (%) (lower values indicate better body composition).
|
Baseline
|
|
Skeletal Muscle Mass
Time Frame: Baseline
|
Skeletal muscle mass measured using InBody analyzer.
Unit: Kilograms (higher values indicate greater muscle mass).
|
Baseline
|
|
Cardiorespiratory Endurance
Time Frame: Baseline
|
Performance on standardized shuttle run test.
Unit: Seconds (shorter time indicates better endurance).
|
Baseline
|
|
Handgrip Strength
Time Frame: Baseline
|
Grip strength measured using digital dynamometer.
Unit: Kilograms (higher values indicate greater strength).
|
Baseline
|
|
Pinch Strength
Time Frame: Baseline
|
Pinch force measured with a pinch gauge.
Unit: Kilograms (higher values indicate greater strength).
|
Baseline
|
|
Flexibility Test
Time Frame: Baseline
|
Sit and reach distance measured in centimeters.
Unit: Centimeters (higher values indicate greater flexibility).
|
Baseline
|
|
Balance Ability
Time Frame: Baseline
|
Time maintaining one-leg stance without support.
Unit: Seconds (longer time indicates better balance).
|
Baseline
|
|
Arch Index
Time Frame: Baseline
|
Foot arch index derived from footprint analysis.
Unit: Ratio (0.2-0.3 indicates normal arch).
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Baseline
|
|
Achilles Tendon Alignment
Time Frame: Baseline
|
Deviation angle of Achilles tendon alignment.
Unit: Degrees (smaller angles indicate better alignment).
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Chia-Ling Chen, MD, PhD, Chang Gung Memorial Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2024
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Study Registration Dates
First Submitted
August 29, 2025
First Submitted That Met QC Criteria
November 18, 2025
First Posted (Actual)
November 20, 2025
Study Record Updates
Last Update Posted (Actual)
November 20, 2025
Last Update Submitted That Met QC Criteria
November 18, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Talipes
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Lower Extremity Deformities, Congenital
- Limb Deformities, Congenital
- Foot Deformities
- Foot Deformities, Acquired
- Foot Deformities, Congenital
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Flatfoot
- Investigative Techniques
- Methods
- Observation
Other Study ID Numbers
- 202400647B0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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