Flat FootPhase 4NCT02414087
Therapeutic Effects of Customized Insoles on Children With Flat Foot
A Phase 4 study testing ICB Medical insoles in people with Flat Foot, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch-support shoe insoles to children with flat foot. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Flat Foot
- What is being tested?
- ICB Medical insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2015to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- flat foot
Who cannot join
- age less than 3 years old or older than 10 years old
- pathological flat foot
Trial locations and contacts
1 site in 1 country.
About this study
Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch-support shoe insoles to children with flat foot.
Read the detailed description
A total of 52 children with flat foot will be collected. The participants will be randomized into two groups, including study group (insoles group) and control group (without insole group).
All participants in the insoles group will be evaluated at baseline, that is before the customized full-length shoe insoles are prescribed. All the evaluations, including physical functional ability, balance, physical activity, functional performance, and quality of life will be re-evaluated up to 12 weeks after shoe insoles wearing in the insoles group.
The control group will be evaluated at the baseline and up to 12 weeks.
- Conditions
- Flat Foot
- Being tested
- ICB Medical insoles
- Keywords
- flat foot, therapeutic effect, insoles, children
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICB Medical insolesDevice
Study group:
Participants in the study group will be prescribed with customized full-length insoles (ICB Medical) to keep the subtalar joint in neutral position, using self chosen comfortable shoes, for 3 months.
Control group:
Participants in the control group will not be prescribed with customized full-length insoles (ICB Medical) to keep the subtalar joint in neutral position, using self chosen comfortable shoes, for 3 months
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | ICB Medical Insoles Receives: Device: ICB Medical insoles |
| control group | Placebo comparator | without ICB Medical insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
health related quality of life (Pediatric Quality of Life Inventory (PedQoL)
Pediatric Quality of Life Inventory (PedQoL)
Measured: baseline and up to 12 weeks
Secondary outcomes (1)
functional performance (Pediatric Outcome Data Collection Instrument)
Pediatric Outcome Data Collection Instrument
Measured: baseline and up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Flat FootStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Ru-Lan Hsieh, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414087
- Sponsor's protocol ID
- SKH-8302-104-DR-29
- Status last verified
- Apr 2015
- First submitted
- 27 Mar 2015
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub4.
PubMed 35080267Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 14;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub3.
PubMed 35029841
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Customized Insoles on Children With Flat Foot
- ClinicalTrials.gov ID
- NCT02414087
- Acronym / sponsor ID
- SKH-8302-104-DR-29
- Conditions
- Flat Foot
- Keywords
- flat foot, therapeutic effect, insoles, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Apr 2015 (estimated)
- 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.
Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch-support shoe insoles to children with flat foot.
Detailed description
A total of 52 children with flat foot will be collected. The participants will be randomized into two groups, including study group (insoles group) and control group (without insole group).
All participants in the insoles group will be evaluated at baseline, that is before the customized full-length shoe insoles are prescribed. All the evaluations, including physical functional ability, balance, physical activity, functional performance, and quality of life will be re-evaluated up to 12 weeks after shoe insoles wearing in the insoles group.
The control group will be evaluated at the baseline and up to 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Device: ICB Medical insolesICB Medical Insoles |
| control group | Placebo comparator | –without ICB Medical insoles |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- flat foot
Key exclusion criteria (2 listed)
- age less than 3 years old or older than 10 years old
- pathological flat foot
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 |
|---|---|---|
| ICB Medical insolesStudy group: Participants in the study group will be prescribed with customized full-length insoles (ICB Medical) to keep the subtalar joint in neutral position, using self chosen comfortable shoes, for 3 months. Control group: Participants in the control group will not be prescribed with customized full-length insoles (ICB Medical) to keep the subtalar joint in neutral position, using self chosen comfortable shoes, for 3 months | Device | study group |
Primary outcome
health related quality of life (Pediatric Quality of Life Inventory (PedQoL)
Time frame: baseline and up to 12 weeks
Pediatric Quality of Life Inventory (PedQoL)
1 secondary outcome
functional performance (Pediatric Outcome Data Collection Instrument)
Time frame: baseline and up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
- Derived from this study: PubMed 35080267Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub4.
- Derived from this study: PubMed 35029841Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 14;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub3.
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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.
Ru-Lan Hsieh, MD principal investigator
Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ICB Medical insoles in people with Flat Foot, run by Taipei Medical University 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 2 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: status not confirmed, as of the sponsor's last update on 10 Apr 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ru-Lan Hsieh, MD (886-2-28332211 ext. 2538, M001052@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health related quality of life (Pediatric Quality of Life Inventory (PedQoL) (time frame: baseline and up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02414087, which also lists 2 linked publications.
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 10 Apr 2015.