UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063406 |
|---|---|
| Receipt number | R000072570 |
| Scientific Title | Exploratory Study of Longitudinal Changes in Cognitive Function and Hand Function Before and After Participation in a Handcraft Program Among Community-Dwelling Older Adults |
| Date of disclosure of the study information | 2026/10/25 |
| Last modified on | 2026/10/25 08:44:22 |
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Basic information
Public title
Study of Changes in Cognitive Function and Hand Sensorimotor Function Before and After Participation in a Handcraft Program Among Community-Dwelling Older Adults
Acronym
Handcraft Program and Changes in Cognitive and Hand Function
Scientific Title
Exploratory Study of Longitudinal Changes in Cognitive Function and Hand Function Before and After Participation in a Handcraft Program Among Community-Dwelling Older Adults
Scientific Title:Acronym
Longitudinal Changes in Cognitive and Hand Function Following Participation in a Handcraft Program
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore longitudinal changes in cognitive function and hand function before, immediately after, and six months after participation in a handcraft program incorporating hand sensorimotor activities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
Executive function and processing speed
Key secondary outcomes
Global cognitive function, hand sensory function, and hand motor function (dexterity and grip strength)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants attend a 12-session handcraft program conducted with the support of trained facilitators. The program combines hand sensory stimulation activities and hand dexterity activities and is conducted once weekly for 90 minutes. Cognitive function and hand function assessments are performed at baseline (T1), immediately after the program (T2), and at a 6-month follow-up (T3).
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Community-dwelling older adults who are members of the Itabashi Silver Human Resources Center and provide written informed consent to participate in the study.
Key exclusion criteria
Individuals judged by the principal investigator to be unable to safely participate in the handcraft program or complete the cognitive assessments, including severe impairment of hand motor or sensory function, severe visual or hearing impairment, or inability to provide informed consent.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | N/A |
| Last name | Matsunaga |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Social Participation and Healthy Aging
Zip code
1730004
Address
8F Itabashi Center Building 3-9-7 Itabashi, Itabashi-ku, Tokyo, JAPAN
TEL
03-6905-6781
hiroko_m@tmig.or.jp
Public contact
Name of contact person
| 1st name | Kimi |
| Middle name | Estela |
| Last name | Kobayashi-Cuya |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Social Participation and Healthy Aging
Zip code
173-0004
Address
8F Itabashi Center Building3-9-7 Itabashi, Itabashi-ku, Tokyo, JAPAN
TEL
03-6905-6781
Homepage URL
kimiestela@hotmail.com
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Kimi Estela Kobayashi-Cuya
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Public Interest Incorporated Foundation Itabashi Silver Human Resources Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan
Tel
03-3964-3241
naomi_hasegawa@tmghig.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
Tokyo Metropolitan Institute for Geriatrics and Gerontology (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2028 | Year | 06 | 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
| 2026 | Year | 10 | Month | 25 | Day |
Last modified on
| 2026 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072570
