UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055003 |
|---|---|
| Receipt number | R000062220 |
| Scientific Title | Introduction of a Stretch Continuation Support Program for School Age Children with pectus excavatum |
| Date of disclosure of the study information | 2024/07/25 |
| Last modified on | 2025/07/25 12:10:24 |
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Basic information
Public title
Introduction of a Stretch Continuation Support Program for School Age Children with pectus excavatum
Acronym
Introduction of a Stretch Continuation Support Program for School Age Children with pectus excavatum
Scientific Title
Introduction of a Stretch Continuation Support Program for School Age Children with pectus excavatum
Scientific Title:Acronym
Stretch Continuation Support Program for School Age Children with pectus excavatum
Region
| Japan |
Condition
Condition
Pectus excavatum
Classification by specialty
| Surgery in general | Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this project is to implement and evaluate a stretching continuum support program for school-age children with Pectus excavatum
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Results of stretching effort Card (percentage of stretching performed per month)
Key secondary outcomes
Qualitative data by the interview
Questionnaire survey of support programs
Chest X-ray results
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Stretch (From five minutes)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children with Pectus excavatum between the ages of 6 and 12 years who are preoperative and not in the habit of stretching
Key exclusion criteria
The child must be habitual in stretching (similar stretching for at least 3 months) and unable to communicate in an age-appropriate manner (with a diagnosis of mental retardation or intellectual disability)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kiyoka |
| Middle name | |
| Last name | Inoue |
Organization
Kawasaki University of Medical and Welfare
Division name
Department of Nursing
Zip code
701-0193
Address
288,Matsushima,Kurashiki Okayama
TEL
0864621111
k.inoue@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Kiyoka |
| Middle name | |
| Last name | Inoue |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Nursing
Zip code
701-0193
Address
288,Matsushima,Kurashiki Okayama
TEL
0864621111
Homepage URL
k.inoue@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki University of Medical Welfare
Address
288,Matsushima,Kurashiki Okayama
Tel
0864621111
kenkyu@mw.kawasaki-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 17 | Day |
Last modified on
| 2025 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062220
