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The Effect of Orthosis and Exercise in Pes Planus

Sponsor
Ju Seok Ryu (Other)
Overall Status
Recruiting
CT.gov ID
NCT03494374
Collaborator
(none)
200
Enrollment
1
Location
1
Arm
63
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: UCBL orthosis
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Annual evaluation after applying UCBL and exercise treatment. Cohort study.Annual evaluation after applying UCBL and exercise treatment. Cohort study.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Orthosis and Exercise in Pes Planus
Actual Study Start Date :
Dec 29, 2016
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment group

Treatment with UCBL and exercise therapy

Device: UCBL orthosis
toe walking exercise
Other Names:
  • Exercise

    		•

    Outcome Measures

    Primary Outcome Measures

    1. TM angle [through study completion, an average of 1 year]

      Talometatarsal angle

    Secondary Outcome Measures

    1. CP angle [through study completion, an average of 1 year]

      Calcaneal pitch angle

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Clinically diagnosed with pes planus

    • Calcaneal pitch angle < 15 degree

    Exclusion Criteria:

    • peripheral neuropathy

    • infection

    • rheumatoid arthritis

    • operation history

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul national university bundang hospital Seongnam-si Bundang-gu Korea, Republic of 13354

    Sponsors and Collaborators

    • Ju Seok Ryu

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ju Seok Ryu, associate professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03494374
    Other Study ID Numbers:
    • B-1701/377-303
    First Posted:
    Apr 11, 2018
    Last Update Posted:
    Nov 8, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ju Seok Ryu, associate professor, Seoul National University Hospital
    pes planus
    UCBL
    exercise
    Additional relevant MeSH terms:
    Flatfoot

    Study Results

    No Results Posted as of Nov 8, 2021