FlatfootNCT07238270
Research on Physical Fitness and Flatfoot in Children
An observational study of Flatfoot, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Flatfoot
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2024to 31 May 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 600 children aged 1-18 years from northern Taiwan
Who may be able to join
- -Children aged 1-18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Flatfoot
- Being tested
- No intervention (observational study)
- Keywords
- physical fitness, flatfoot
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
This is an observational study with no intervention.
| Study group | Role | What they receive |
|---|---|---|
| preschool students | Children aged about 1-6 years from northern Taiwan. Receives: Other: No intervention (observational study) | |
| primary school students | Children aged about 7-12 years from northern Taiwan. Receives: Other: No intervention (observational study) | |
| middle school students | Children aged about 13-15 years from northern Taiwan. Receives: Other: No intervention (observational study) | |
| high school students | Adolescents aged about 16-18 years from northern Taiwan. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire Score
Score from a self-designed questionnaire on lifestyle habits and foot-related symptoms. Scale range: higher scores = better habits, fewer symptoms.
Measured: Baseline
Body Fat Percentage
Body fat percentage measured using InBody analyzer. Unit: Percent (%) (lower values indicate better body composition).
Measured: Baseline
Skeletal Muscle Mass
Skeletal muscle mass measured using InBody analyzer. Unit: Kilograms (higher values indicate greater muscle mass).
Measured: Baseline
Cardiorespiratory Endurance
Performance on standardized shuttle run test. Unit: Seconds (shorter time indicates better endurance).
Measured: Baseline
Handgrip Strength
Grip strength measured using digital dynamometer. Unit: Kilograms (higher values indicate greater strength).
Measured: Baseline
Pinch Strength
Pinch force measured with a pinch gauge. Unit: Kilograms (higher values indicate greater strength).
Measured: Baseline
Flexibility Test
Sit and reach distance measured in centimeters. Unit: Centimeters (higher values indicate greater flexibility).
Measured: Baseline
Balance Ability
Time maintaining one-leg stance without support. Unit: Seconds (longer time indicates better balance).
Measured: Baseline
Arch Index
Foot arch index derived from footprint analysis. Unit: Ratio (0.2-0.3 indicates normal arch).
Measured: Baseline
Achilles Tendon Alignment
Deviation angle of Achilles tendon alignment. Unit: Degrees (smaller angles indicate better alignment).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 May 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlatfootStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, MD, PhD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238270
- Sponsor's protocol ID
- 202400647B0
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Physical Fitness and Flatfoot in Children
- ClinicalTrials.gov ID
- NCT07238270
- Acronym / sponsor ID
- 202400647B0
- Conditions
- Flatfoot
- Keywords
- physical fitness, flatfoot
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| preschool students | – | Other: No intervention (observational study)Children aged about 1-6 years from northern Taiwan. |
| primary school students | – | Other: No intervention (observational study)Children aged about 7-12 years from northern Taiwan. |
| middle school students | – | Other: No intervention (observational study)Children aged about 13-15 years from northern Taiwan. |
| high school students | – | Other: No intervention (observational study)Adolescents aged about 16-18 years from northern Taiwan. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 600 children aged 1-18 years from northern Taiwan
Key inclusion criteria (1 listed)
- -Children aged 1-18 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)This is an observational study with no intervention. | Other | high school students, middle school students, preschool students, primary school students |
Primary outcome
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.
Body Fat Percentage
Time frame: Baseline
Body fat percentage measured using InBody analyzer. Unit: Percent (%) (lower values indicate better body composition).
Skeletal Muscle Mass
Time frame: Baseline
Skeletal muscle mass measured using InBody analyzer. Unit: Kilograms (higher values indicate greater muscle mass).
Cardiorespiratory Endurance
Time frame: Baseline
Performance on standardized shuttle run test. Unit: Seconds (shorter time indicates better endurance).
Handgrip Strength
Time frame: Baseline
Grip strength measured using digital dynamometer. Unit: Kilograms (higher values indicate greater strength).
Pinch Strength
Time frame: Baseline
Pinch force measured with a pinch gauge. Unit: Kilograms (higher values indicate greater strength).
Flexibility Test
Time frame: Baseline
Sit and reach distance measured in centimeters. Unit: Centimeters (higher values indicate greater flexibility).
Balance Ability
Time frame: Baseline
Time maintaining one-leg stance without support. Unit: Seconds (longer time indicates better balance).
Arch Index
Time frame: Baseline
Foot arch index derived from footprint analysis. Unit: Ratio (0.2-0.3 indicates normal arch).
Achilles Tendon Alignment
Time frame: Baseline
Deviation angle of Achilles tendon alignment. Unit: Degrees (smaller angles indicate better alignment).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Ling Chen, MD, PhD study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Flatfoot, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire Score (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.