- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03494374
The Effect of Orthosis and Exercise in Pes Planus
April 19, 2024 updated by: Ju Seok Ryu
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.
Study Overview
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 Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bundang-gu
-
Seongnam-si, Bundang-gu, Korea, Republic of, 13354
- Recruiting
- Seoul National University Bundang Hospital
-
Contact:
- JUSEOK RYU, PhD
- Phone Number: 031-787-7733 010-4382-2328
- Email: jseok337@daum.net
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 10 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Clinically diagnosed with pes planus
- Calcaneal pitch angle < 15 degree
Exclusion Criteria:
- peripheral neuropathy
- infection
- rheumatoid arthritis
- operation history
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment group
Treatment with UCBL and exercise therapy
|
toe walking exercise
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TM angle
Time Frame: through study completion, an average of 1 year
|
Talometatarsal angle
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CP angle
Time Frame: through study completion, an average of 1 year
|
Calcaneal pitch angle
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 29, 2016
Primary Completion (Estimated)
September 29, 2025
Study Completion (Estimated)
November 29, 2026
Study Registration Dates
First Submitted
April 2, 2018
First Submitted That Met QC Criteria
April 10, 2018
First Posted (Actual)
April 11, 2018
Study Record Updates
Last Update Posted (Actual)
April 22, 2024
Last Update Submitted That Met QC Criteria
April 19, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1701/377-303
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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