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NCT Number: NCT03494374

The Effect of Orthosis and Exercise in Pes Planus

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.

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Key information

Conditions

Pes Planus Behavior Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Flatfoot Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Motor Activity Musculoskeletal Abnormalities Musculoskeletal Diseases Talipes

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul national university bundang hospital

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

Location status: Recruiting

Location contact

JUSEOK RYU, PhD

CONTACT

[email protected]

010-4382-2328 ext. 031-787-7733

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • peripheral neuropathy
  • infection
  • rheumatoid arthritis
  • operation history

Treatment and study plan

UCBL orthosis

Device

toe walking exercise

Other names: Exercise

Primary outcomes

  1. TM angle

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

    Talometatarsal angle

Secondary outcomes

  1. CP angle

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

    Calcaneal pitch angle

Sponsors and collaborators

Lead sponsor

Ju Seok Ryu

Other

Registry information

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Apr 11, 2018
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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