The Effect of Orthosis and Exercise in Pes Planus

Not Applicable

Recruiting

• Conditions: Pes Planus
• Interventions: Device: UCBL orthosis

• Registration Number: NCT03494374
• Lead Sponsor: Ju Seok Ryu

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.

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 Timeline

• Study Start: 2016-12-29
• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22
• Primary Completion: 2025-09-29
• Study Completion: 2026-11-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• peripheral neuropathy
• infection
• rheumatoid arthritis
• operation history

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	UCBL orthosis	Treatment with UCBL and exercise therapy

Primary Outcome Measures

Name	Time	Method
TM angle	through study completion, an average of 1 year	Talometatarsal angle

Secondary Outcome Measures

Name	Time	Method
CP angle	through study completion, an average of 1 year	Calcaneal pitch angle

Trial Locations

Locations (1)

Seoul national university bundang hospital; 🇰🇷 Seongnam-si, Bundang-gu, Korea, Republic of