UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053321 |
|---|---|
| Receipt number | R000060863 |
| Scientific Title | A Study Exploring the Effects of Physiotherapy on Mental Condition |
| Date of disclosure of the study information | 2024/01/15 |
| Last modified on | 2024/01/11 11:41:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study Exploring the Effects of Physiotherapy on Mental Condition
Acronym
Exploring the Effects of Physiotherapy on Mental Condition
Scientific Title
A Study Exploring the Effects of Physiotherapy on Mental Condition
Scientific Title:Acronym
Exploring the Effects of Physiotherapy on Mental Condition
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of physiotherapy on mental condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
applying physiotherapy procedures
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply Care A for 15 min > More than 1 week washout > Apply Care B for 15 min
Interventions/Control_2
Apply Care B for 15 min > More than 1 week washout > Apply Care A for 15 min
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Healthy male aged 20-59
2. Person who voluntarily give their consent to participate in the study after receiving written explanations.
Key exclusion criteria
1. Person who had a drug allergic reaction.
2. Person who has one of the five major diseases (cancer, stroke, acute myocardial infarction, diabetes, psychiatric disease) and are undergoing treatment at a medical institution or are planning surgery.
3. Person who is judged by the principal investigator to be inappropriate to participate in the research due to other reasons such as noncompliance with compliance obligations.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Ryotaro |
| Middle name | |
| Last name | Yanagisawa |
Organization
Kao Corporation
Division name
Human health care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7282
yanagisawa.ryoutarou@kao.com
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Sato |
Organization
Kao Corporation
Division name
Human health care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7282
Homepage URL
satou.tomoya@kao.com
Sponsor or person
Institute
Kao Corporation
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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 | 01 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 04 | 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
| 2024 | Year | 01 | Month | 11 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060863
