Back to resultsThe Effect of Orthosis and Exercise in Pes Planus
Primary Purpose
Pes Planus
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
UCBL orthosis
Sponsored by
About this trial
This is an interventional treatment trial for Pes Planus focused on measuring pes planus, UCBL, exercise
Eligibility Criteria
Inclusion Criteria:
- Clinically diagnosed with pes planus
- Calcaneal pitch angle < 15 degree
Exclusion Criteria:
- peripheral neuropathy
- infection
- rheumatoid arthritis
- operation history
Sites / Locations
- Seoul national university bundang hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment group
Arm Description
Treatment with UCBL and exercise therapy
Outcomes
Primary Outcome Measures
TM angle
Talometatarsal angle
Secondary Outcome Measures
CP angle
Calcaneal pitch angle
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03494374
Brief Title
The Effect of Orthosis and Exercise in Pes Planus
Official Title
The Effect of Orthosis and Exercise in Pes Planus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2016 (Actual)
Primary Completion Date
September 29, 2023 (Anticipated)
Study Completion Date
November 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ju Seok Ryu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pes Planus
Keywords
pes planus, UCBL, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Annual evaluation after applying UCBL and exercise treatment. Cohort study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
Treatment with UCBL and exercise therapy
Intervention Type
Device
Intervention Name(s)
UCBL orthosis
Other Intervention Name(s)
Exercise
Intervention Description
toe walking exercise
Primary Outcome Measure Information:
Title
TM angle
Description
Talometatarsal angle
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
CP angle
Description
Calcaneal pitch angle
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinically diagnosed with pes planus
Calcaneal pitch angle < 15 degree
Exclusion Criteria:
peripheral neuropathy
infection
rheumatoid arthritis
operation history
Facility Information:
Facility Name
Seoul national university bundang hospital
City
Seongnam-si
State/Province
Bundang-gu
ZIP/Postal Code
13354
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JUSEOK RYU, PhD
Phone
010-4382-2328
Ext
031-787-7733
Email
jseok337@daum.net
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Effect of Orthosis and Exercise in Pes Planus
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