Pes PlanusNCT03494374
The Effect of Orthosis and Exercise in Pes Planus
A study testing UCBL orthosis in people with Pes Planus, run by Ju Seok Ryu at 1 site in South Korea.
Trial summary
There is no definite evidence for the conservative treatment of pes planus. We want to verify the combination efficacy of orthosis and toe walking exercise for the treatment of pes planus. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Pes Planus
- What is being tested?
- UCBL orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Dec 2016to 29 Nov 2026
- Phase
- Interventional
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinically diagnosed with pes planus
- Calcaneal pitch angle < 15 degree
Who cannot join
- peripheral neuropathy
- infection
- rheumatoid arthritis
- operation history
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul national university bundang hospital
Seongnam-si, Bundang-gu, 13354
JUSEOK RYU, PhD, 010-4382-2328 ext. 031-787-7733, jseok337@daum.net
About this study
There is no definite evidence for the conservative treatment of pes planus. We want to verify the combination efficacy of orthosis and toe walking exercise for the treatment of pes planus.
Read the detailed description
Observation cohort study
We prescribe UCBL orthosis and teach toe walking exercise. And we will check standing foot radiography (AP/Lateral) annually. And we will compare the changes of talometatarsal angle and calcaneal pitch angle.
- Conditions
- Pes Planus
- Being tested
- UCBL orthosis
- Keywords
- pes planus, UCBL, exercise
- Medical subject headings
- Flatfoot, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCBL orthosisDevice
Also called Exercise
toe walking exercise
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Treatment with UCBL and exercise therapy Receives: Device: UCBL orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
TM angle
Talometatarsal angle
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
CP angle
Calcaneal pitch angle
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start29 Dec 2016
- Primary completion29 Sep 2025 (estimated)
- Study completion29 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pes PlanusStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Annual evaluation after applying UCBL and exercise treatment. Cohort study.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ju Seok Ryu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ju Seok Ryu, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494374
- Sponsor's protocol ID
- B-1701/377-303
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2018
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Orthosis and Exercise in Pes Planus
- ClinicalTrials.gov ID
- NCT03494374
- Acronym / sponsor ID
- B-1701/377-303
- Conditions
- Pes Planus
- Keywords
- pes planus, UCBL, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ju Seok RyuUniversity, hospital or other
- Study start
- 29 Dec 2016 (actual)
- Primary completion
- 29 Sep 2025 (estimated)
- Study completion
- 29 Nov 2026 (estimated)
- First posted
- 11 Apr 2018 (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.
There is no definite evidence for the conservative treatment of pes planus. We want to verify the combination efficacy of orthosis and toe walking exercise for the treatment of pes planus.
Detailed description
Observation cohort study
We prescribe UCBL orthosis and teach toe walking exercise. And we will check standing foot radiography (AP/Lateral) annually. And we will compare the changes of talometatarsal angle and calcaneal pitch angle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Annual evaluation after applying UCBL and exercise treatment. Cohort study.
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: UCBL orthosisTreatment with UCBL and exercise therapy |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinically diagnosed with pes planus
- Calcaneal pitch angle < 15 degree
Key exclusion criteria (4 listed)
- peripheral neuropathy
- infection
- rheumatoid arthritis
- operation history
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 |
|---|---|---|
| UCBL orthosisAlso: Exercisetoe walking exercise | Device | treatment group |
Primary outcome
TM angle
Time frame: through study completion, an average of 1 year
Talometatarsal angle
1 secondary outcome
CP angle
Time frame: through study completion, an average of 1 year
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 22 Apr 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UCBL orthosis in people with Pes Planus, run by Ju Seok Ryu at 1 site in South Korea.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Apr 2024. 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 South Korea. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TM angle (time frame: through study completion, an average of 1 year). 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 22 Apr 2024.