Flatfoot, FlexibleNCT05533762
The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot
A study of Flatfoot, Flexible, run by Taipei Medical University WanFang Hospital.
Trial summary
Flexible flatfoot is a condition that increase the load of the foot structure.With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures… Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Flatfoot, Flexible
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2022to 31 Dec 2023
- Phase
- Interventional
- 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
- Children presenting symptomatic flexible flatfoot only
Who cannot join
- Children with a history of foot injury or surgery, foot abnormalities or a confirmed diagnosis such as neurological deficits.
Trial locations and contacts
No sites are listed yet.
About this study
Flexible flatfoot is a condition that increase the load of the foot structure.With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot.
Read the detailed description
Flexible flatfoot is a condition that involves the collapse of the medial longitudinal arch of the foot during weight-bearing stress and the restoration of the arch after the removal of body weight.
Flatfoot may increase the load of the foot structure, potentially interfering with normal foot function. With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot, pain in the plantar foot, and instability of the medial foot structure. Treatment effect of corrective shoes or insoles on flexible flatfoot in children remain uncertain.
In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot. The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation.
The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation.
- Conditions
- Flatfoot, Flexible
- Being tested
- arch insole and sham insole
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arch insole and sham insoleDevice
children wear insoles on feet
| Study group | Role | What they receive |
|---|---|---|
| arch insole | Active comparator | Half of the subjects are randomly assigned to assess balance capacity with arch insole first.
Three day wash out, the subjects are assess balance capacity with sham insole. Receives: Device: arch insole and sham insole |
| sham insole | Sham comparator | Half of the subjects are randomly assigned to assess balance capacity with sham insole first.
Three day wash out, the subjects are assess balance capacity with arch insole. Receives: Device: arch insole and sham insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Reach Test(FRT) from pre to post-intervention.
The Functional Reach Test (FRT) is a quick screen for determining balance capacity.
Measured: up to 10 minutes
Pediatric Berg Balance Scale
Pediatric Berg Balance Scale was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks.
Maximum score is 56 ,and minimum values is 0. Score 54-56 means a better outcome.
Measured: up to 30 minutes
Secondary outcomes (1)
Change in Center of pressure (CoP) from pre to post-intervention.
The center of pressure (CoP) measures derived from the foot pressure mat and force plate of RSSCAN system.
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start15 Sep 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flatfoot, FlexibleStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YenTing LIU, Master, Study chair, Wang Fang Hospital, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533762
- Sponsor's protocol ID
- N202106064
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot
- ClinicalTrials.gov ID
- NCT05533762
- Acronym / sponsor ID
- N202106064
- Conditions
- Flatfoot, Flexible
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 15 Sep 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Sep 2022 (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.
Flexible flatfoot is a condition that increase the load of the foot structure.With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot.
Detailed description
Flexible flatfoot is a condition that involves the collapse of the medial longitudinal arch of the foot during weight-bearing stress and the restoration of the arch after the removal of body weight.
Flatfoot may increase the load of the foot structure, potentially interfering with normal foot function. With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot, pain in the plantar foot, and instability of the medial foot structure. Treatment effect of corrective shoes or insoles on flexible flatfoot in children remain uncertain.
In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot. The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation.
The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arch insole | Active comparator | Device: arch insole and sham insoleHalf of the subjects are randomly assigned to assess balance capacity with arch insole first. Three day wash out, the subjects are assess balance capacity with sham insole. |
| sham insole | Sham comparator | Device: arch insole and sham insoleHalf of the subjects are randomly assigned to assess balance capacity with sham insole first. Three day wash out, the subjects are assess balance capacity with arch insole. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children presenting symptomatic flexible flatfoot only
Key exclusion criteria (1 listed)
- Children with a history of foot injury or surgery, foot abnormalities or a confirmed diagnosis such as neurological deficits.
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 |
|---|---|---|
| arch insole and sham insolechildren wear insoles on feet | Device | arch insole, sham insole |
Primary outcome
Change in Functional Reach Test(FRT) from pre to post-intervention.
Time frame: up to 10 minutes
The Functional Reach Test (FRT) is a quick screen for determining balance capacity.
Pediatric Berg Balance Scale
Time frame: up to 30 minutes
Pediatric Berg Balance Scale was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks. Maximum score is 56 ,and minimum values is 0. Score 54-56 means a better outcome.
1 secondary outcome
Change in Center of pressure (CoP) from pre to post-intervention.
Time frame: up to 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: No
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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.
YenTing LIU, Master study chair
Wang Fang Hospital, Taipei Medical University
Questions about this trial
What is this clinical trial studying?
A study of Flatfoot, Flexible, run by Taipei Medical University WanFang Hospital.
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 1 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 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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 YenTing LIU (+886-229307930 ext. 1612, 95175@w.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Reach Test(FRT) from pre to post-intervention. (time frame: up to 10 minutes). The study lists 2 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 9 Sep 2022.