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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

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

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Keywords

  • pes planus
  • UCBL
  • exercise
03

Who can participate

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • peripheral neuropathy
  • infection
  • rheumatoid arthritis
  • operation history
04

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

05

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

06

Study locations

1 of 1 sites recruiting
  • Seoul national university bundang hospital
    Seongnam-si, Bundang-gu 13354, Korea, Republic of
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

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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