出境医 / 临床实验 / The Effect of Orthosis and Exercise in Pes Planus

The Effect of Orthosis and Exercise in Pes Planus

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
Pes Planus Device: UCBL orthosis Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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 : December 29, 2016
Actual Primary Completion Date : February 26, 2020
Actual Study Completion Date : February 26, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: treatment group
Treatment with UCBL and exercise therapy
Device: UCBL orthosis
toe walking exercise
Other Name: Exercise

Outcome Measures
Primary Outcome Measures :
  1. TM angle [ Time Frame: through study completion, an average of 1 year ]
    Talometatarsal angle


Secondary Outcome Measures :
  1. CP angle [ Time Frame: through study completion, an average of 1 year ]
    Calcaneal pitch angle


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Layout table for location information
Korea, Republic of
Seoul national university bundang hospital
Seongnam-si, Bundang-gu, Korea, Republic of, 13354
Sponsors and Collaborators
Ju Seok Ryu

Tracking Information
First Submitted Date  ICMJE April 2, 2018
First Posted Date  ICMJE April 11, 2018
Last Update Posted Date July 21, 2020
Actual Study Start Date  ICMJE December 29, 2016
Actual Primary Completion Date February 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
TM angle [ Time Frame: through study completion, an average of 1 year ]
Talometatarsal angle
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
CP angle [ Time Frame: through study completion, an average of 1 year ]
Calcaneal pitch angle
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Orthosis and Exercise in Pes Planus
Official Title  ICMJE The Effect of Orthosis and Exercise in Pes Planus
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Annual evaluation after applying UCBL and exercise treatment. Cohort study.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pes Planus
Intervention  ICMJE Device: UCBL orthosis
toe walking exercise
Other Name: Exercise
Study Arms  ICMJE Experimental: treatment group
Treatment with UCBL and exercise therapy
Intervention: Device: UCBL orthosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2020)
86
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2018)
100
Actual Study Completion Date  ICMJE February 26, 2020
Actual Primary Completion Date February 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • peripheral neuropathy
  • infection
  • rheumatoid arthritis
  • operation history
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03494374
Other Study ID Numbers  ICMJE B-1701/377-303
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Ju Seok Ryu, Seoul National University Hospital
Study Sponsor  ICMJE Ju Seok Ryu
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP