UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056637 |
|---|---|
| Receipt number | R000064737 |
| Scientific Title | Verification of the effectiveness of the recollection method using tactile sensation |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2025/01/06 15:10:49 |
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Basic information
Public title
Verification of the effectiveness of the recollection method using tactile sensation
Acronym
Verification of the effectiveness of the recollection method using tactile sensation
Scientific Title
Verification of the effectiveness of the recollection method using tactile sensation
Scientific Title:Acronym
Verification of the effectiveness of the recollection method using tactile sensation
Region
| Japan |
Condition
Condition
Psychological and cognitive functions
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of the recollection method using tactile sensation on psychological and cognitive functions in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological and cognitive functions
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Recollection using tactile sensation will be conducted once a week for one hour for 10 weeks.
Interventions/Control_2
Spending life as usual
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
| 70 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Age 70 years or older and 79 years or younger (at the time of registration)
(2) Persons who have given their written consent to participate in the research
Key exclusion criteria
(1) Those who cannot give informed consent
(2) Those with a history or current history of dementia or psychiatric/neurological disorders
(3) Those who score 23 or less on the dementia screening test (MMSE-J), which is administered as a pre-test
(4) Those with severe visual or hearing impairment
(5) Those who are currently participating in other clinical research studies
(6) Those who have other difficulties in conducting the study
(7) Those who have difficulty completing the questionnaire via web form.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Smart Ageing International Research Center
Zip code
980-8575
Address
4-1 Seiryo-Machi, Aoba-ku, 980-8575, Sendai, Japan
TEL
022-717-8824
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Oba |
Organization
Tohoku University
Division name
Smart Ageing International Research Center
Zip code
980-8575
Address
4-1 Seiryo-Machi, Aoba-ku, 980-8575, Sendai, Japan
TEL
022-717-8824
Homepage URL
kentaro.oba.c6@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Mitsui Chemicals, Inc.
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
ec-med@grp.tohoku.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 | 01 | Month | 06 | 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
| 2024 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 08 | 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 | 01 | Month | 06 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064737
