UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000045704 |
|---|---|
| Receipt number | R000051984 |
| Scientific Title | A research on changes in walking figure with sanitary product |
| Date of disclosure of the study information | 2022/10/13 |
| Last modified on | 2023/02/24 18:08:56 |
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Basic information
Public title
A research on changes in walking figure with sanitary product
Acronym
A research on changes in walking figure with sanitary product
Scientific Title
A research on changes in walking figure with sanitary product
Scientific Title:Acronym
A research on changes in walking figure with sanitary product
Region
| Japan |
Condition
Condition
Female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify some kind of gait-improving effect by putting the sanitary panty on the subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Evaluation of walking function
2. Walking movement evaluation
3. Evaluation of muscular strength during walking
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Walking while putting the test panty-1 to the subjects.
Interventions/Control_2
Walking while putting the test panty-2 to the subjects.
Interventions/Control_3
Walking while putting the test panty-3 to the subjects.
Interventions/Control_4
Walking while putting the test panty-4 to the subjects.
Interventions/Control_5
Walking while putting the test panty-5 to the subjects.
Interventions/Control_6
Walking while putting a habitual panty to the subjects.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Female subjects ranging in age from 65 to 74.
(2) Subjects who can give informed consent to take part in this research, after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects who are under the use of some kind of urinary-supporting product (no usage-experience required).
(2) Subjects who have a gait disorder such as dragging their foot, taking a walking stick, handling a walking frame, and so on.
(3) Subjects who break out in a rash from putting a sanitary panty on them.
(4) Others who have been determined as ineligible for the research subject of this research, according to the principal investigator's opinion.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Graduate School of Integrative and Global Majors, Tsukuba University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.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
| 2022 | Year | 10 | Month | 13 | 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
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 08 | Day |
Last modified on
| 2023 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051984
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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