UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052614 |
|---|---|
| Receipt number | R000060040 |
| Scientific Title | Evaluation of the efficacy of non-pharmacological treatment (abdominal pressure band) for pediatric orthostatic dysregulation |
| Date of disclosure of the study information | 2025/10/25 |
| Last modified on | 2023/10/25 18:21:22 |
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Basic information
Public title
Evaluation of the efficacy of non-pharmacological treatment (abdominal pressure band) for pediatric orthostatic dysregulation
Acronym
Evaluation of the efficacy of non-pharmacological treatment (abdominal pressure band) for pediatric orthostatic dysregulation
Scientific Title
Evaluation of the efficacy of non-pharmacological treatment (abdominal pressure band) for pediatric orthostatic dysregulation
Scientific Title:Acronym
Evaluation of the efficacy of non-pharmacological treatment (abdominal pressure band) for pediatric orthostatic dysregulation
Region
| Japan |
Condition
Condition
Orthostatic dysregulation
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of abdominal pressure bands in pediatric patients with orthostatic dysregulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The results of the orthostatic test (autonomic function and cerebral blood flow (NIRS)) will be compared with and without the abdominal pressure band.
Key secondary outcomes
Comparison of effectiveness of abdominal pressure bands by height, weight, BMI, chest Xp, and body composition (InBody)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Standing test performed without abdominal pressure band and then with abdominal pressure band
Interventions/Control_2
Standing test with abdominal pressure band and then without abdominal pressure band
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
| 10 | years-old | <= |
Age-upper limit
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) 10-16 years old
(2) Consent to research
Key exclusion criteria
(1) Have a coexisting disease
(2) Participants who are inappropriate for the conduct of the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | SEIJI |
| Middle name | |
| Last name | YOSHIDA |
Organization
Osaka Medical and Pharmaceutical University
Division name
Pediatrics
Zip code
569-8686
Address
2-7, Daigakumachi, Takatsuki, Osaka
TEL
0726831221
seiji.yoshida@ompu.ac.jp
Public contact
Name of contact person
| 1st name | SEIJI |
| Middle name | |
| Last name | YOSHIDA |
Organization
Osaka Medical and Pharmaceutical University
Division name
Pediatrics
Zip code
569-8686
Address
2-7, Daigakumachi, Takatsuki, Osaka
TEL
0726831221
Homepage URL
seiji.yoshida@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Psychosomatic Pediatrics
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
Osaka Medical and Pharmaceutical University
Address
2-7, Daigakumachi, Takatsuki, Osaka
Tel
0726831221
seiji.yoshida@ompu.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
| 2025 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060040
