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RecruitingNCT03494374Updated Apr 22, 2024

The Effect of Orthosis and Exercise in Pes Planus

An interventional study of UCBL orthosis in Pes Planus, sponsored by Ju Seok Ryu. Recruiting at 1 site in Korea, Republic of. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2024-04-22.

Sponsored by Ju Seok Ryu · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Registered 1 year 3 months after the study started (first participant enrolled Dec 2016, registered Apr 2018).
  • Started Dec 2016; still recruiting 9 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
3 Years to 10 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pes Planus

Keywords

  • pes planus
  • UCBL
  • exercise
03

In context

Flatfoot

173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.

This study's planned enrollment of 200 is above the median of 40 across 122 interventional studies indexed under Flatfoot.

Browse Flatfoot studies →

Lead sponsor

Ju Seok Ryu is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinically diagnosed with pes planus
  • Calcaneal pitch angle \< 15 degree

Exclusion criteria

Exclusion Criteria:

  • peripheral neuropathy
  • infection
  • rheumatoid arthritis
  • operation history
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    treatment group

    Treatment with UCBL and exercise therapy

    Device: UCBL orthosis

Interventions

  • DeviceUCBL orthosis

    toe walking exercise

    Also known as: Exercise

06

What researchers measure

Primary outcomes

  1. TM angle

    Talometatarsal angle

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. CP angle

    Calcaneal pitch angle

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2016 (actual). Primary completion is estimated for Sep 2025, 105 months after the start.

Of 89 non-industry interventional studies with no phase under Flatfoot, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's planned 105 months is above that.

Counting every sponsor, half of 89 studies reached it within 7 months; a quarter within 2 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2018
First posted
Apr 11, 2018
StartActual
Dec 29, 2016
Primary completionEst.
Sep 29, 2025
CompletionEst.
Nov 29, 2026
Last update
Apr 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03494374
Lead sponsor
Ju Seok Ryu
Responsible party
Ju Seok Ryu (associate professor, Seoul National University Hospital) — Sponsor-investigator
First posted
Apr 11, 2018
Start date
Dec 29, 2016
Primary completion
Sep 29, 2025 (estimated)
Completion
Nov 29, 2026 (estimated)
Last update
Apr 22, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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