Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pes Planus | Device: UCBL orthosis | Not Applicable |
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 (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 |
Arm | Intervention/treatment |
---|---|
Experimental: treatment group
Treatment with UCBL and exercise therapy
|
Device: UCBL orthosis
toe walking exercise
Other Name: Exercise
|
Ages Eligible for Study: | 3 Years to 10 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Seoul national university bundang hospital | |
Seongnam-si, Bundang-gu, Korea, Republic of, 13354 |
Tracking Information | |||||
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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 |
TM angle [ Time Frame: through study completion, an average of 1 year ] Talometatarsal angle
|
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
CP angle [ Time Frame: through study completion, an average of 1 year ] Calcaneal pitch angle
|
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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 |
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Condition ICMJE | Pes Planus | ||||
Intervention ICMJE | Device: UCBL orthosis
toe walking exercise
Other Name: Exercise
|
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Study Arms ICMJE | Experimental: treatment group
Treatment with UCBL and exercise therapy
Intervention: Device: UCBL orthosis
|
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
86 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
|
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Sex/Gender ICMJE |
|
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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 |
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IPD Sharing Statement ICMJE |
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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 |