UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060235 |
|---|---|
| Receipt number | R000068897 |
| Scientific Title | A Randomized Crossover Trial on the Effectiveness of Simple Pressure Redistribution Devices on Disaster Cardboard Beds |
| Date of disclosure of the study information | 2025/12/30 |
| Last modified on | 2025/12/30 12:40:25 |
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Basic information
Public title
Effectiveness of Simple Pressure Redistribution Devices on Disaster Cardboard Beds
Acronym
Pressure Redistribution Study on Cardboard Beds
Scientific Title
A Randomized Crossover Trial on the Effectiveness of Simple Pressure Redistribution Devices on Disaster Cardboard Beds
Scientific Title:Acronym
Assessment of Simple Pressure Redistribution Devices on Cardboard Beds
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the extent to which a simple pressure support intervention using materials commonly available in evacuation shelters improves body pressure distribution when using a cardboard bed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sacral interface pressure (mean and maximum values)
Key secondary outcomes
Sacral contact area
Subjective evaluation (Likert scale)
Ease of turning over in bed (Likert scale)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Cardboard bed only
Interventions/Control_2
Blanket
Interventions/Control_3
Towel
Interventions/Control_4
Bubble wrap
Interventions/Control_5
Blanket + towel
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults who provided written informed consent of their own free will after receiving and understanding sufficient explanation of the purpose and procedures of this study
Key exclusion criteria
Individuals who are unable to complete a self-administered questionnaire or who have difficulty following instructions due to cognitive impairment, visual or hearing problems, or other similar reasons.
In addition, individuals deemed inappropriate for participation by the principal investigator or co-investigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Soichiro |
| Middle name | |
| Last name | Koyama |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
470-1192
Address
198 Dengakugakubo, Kutsukake-cho, Toyoake City, Aichi, Japan
TEL
+81-562-93-9000
koyamas@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Soichiro |
| Middle name | |
| Last name | Koyama |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
470-1192
Address
198 Dengakugakubo, Kutsukake-cho, Toyoake City, Aichi, Japan
TEL
+81-562-93-9000
Homepage URL
koyamas@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
The Japanese Association for Disaster Medicine
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
Ethic Committee of Fujita Health University
Address
198 Dengakugakubo, Kutsukake-cho, Toyoake City, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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 | 12 | Month | 30 | 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
33
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
| 2025 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 10 | 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
| 2025 | Year | 12 | Month | 30 | Day |
Last modified on
| 2025 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068897
