UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054410 |
|---|---|
| Receipt number | R000062030 |
| Scientific Title | Development of Brown Splint |
| Date of disclosure of the study information | 2024/05/16 |
| Last modified on | 2025/10/01 18:54:15 |
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Basic information
Public title
Development of Brown Splint
Acronym
Development of Brown Splint
Scientific Title
Development of Brown Splint
Scientific Title:Acronym
Development of Brown Splint
Region
| Japan |
Condition
Condition
artificial knee replacement
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a Brown Splint
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between the subject's body size and Brown Splint
Key secondary outcomes
Comparison between "conventional product group" and "developed product group
The rate of swelling
Difference in pressure on the ground surface of the base
Differences in the location of pain and pain evaluation scale
Differences in the rate and location of skin redness
Differences in post-use impressions
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Brown Splint under development are used
Interventions/Control_2
Use commercially available Brown Splint
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
free and voluntary written consent can be confirmed
Key exclusion criteria
Patients unable to communicate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Mano |
Organization
FUJITA HEALTH UNIVERSITY HOSPITAL
Division name
Nursing Department
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562932111
hp1.nurse@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Watanabe |
Organization
FUJITA HEALTH UNIVERSITY
Division name
Center for Collaboration in Research and Innovation
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562939866
Homepage URL
fuji-san@fujita-hu.ac.jp
Sponsor or person
Institute
FUJITA HEALTH UNIVERSITY HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
FUJITA ACADEMY
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University Research Support Department
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
Tel
0562939635
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
| 2024 | Year | 05 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | 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 | 05 | Month | 16 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062030
