NCT03494374

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Dec 2016Nov 2026

Study Start

First participant enrolled

December 29, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2026

Expected
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

8.8 years

First QC Date

April 2, 2018

Last Update Submit

April 19, 2024

Conditions

Pes Planus

Keywords

pes planusUCBLexercise

Outcome Measures

Primary Outcomes (1)

  • TM angle

    Talometatarsal angle

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • CP angle

    through study completion, an average of 1 year

Study Arms (1)

treatment group

EXPERIMENTAL

Treatment with UCBL and exercise therapy

Device: UCBL orthosis

Interventions

UCBL orthosisDEVICE

toe walking exercise

Also known as: Exercise
treatment group

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • peripheral neuropathy
  • infection
  • rheumatoid arthritis
  • operation history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university bundang hospital

Seongnam-si, Bundang-gu, 13354, South Korea

RECRUITING

MeSH Terms

Conditions

FlatfootMotor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Annual evaluation after applying UCBL and exercise treatment. Cohort study.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 11, 2018

Study Start

December 29, 2016

Primary Completion

September 29, 2025

Study Completion (Estimated)

November 29, 2026

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Locations

KR(1)