UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057189 |
|---|---|
| Receipt number | R000065337 |
| Scientific Title | A study on the effectiveness of an intervention program using fine motor activities |
| Date of disclosure of the study information | 2025/03/03 |
| Last modified on | 2025/11/05 11:27:55 |
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Basic information
Public title
Evaluation of a social participation creative program for older adults (1)
Acronym
Evaluation of a social participation creative program for older adults (1)
Scientific Title
A study on the effectiveness of an intervention program using fine motor activities
Scientific Title:Acronym
A study on the effectiveness of an intervention program using fine motor activities (1)
Region
| Japan |
Condition
Condition
Older adults with mild cognitive impairment
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of a manual dexterity intervention program for maintaining and improving self-efficacy and mental health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Self-efficacy
Key secondary outcomes
Memory function
Language function
Executive function
Attention
Visual function
Hand motor function
Hand sensory function
Psychological health (WHO-5, Rosenberg's self-esteem scale, GDS-15-J)
Social activities (frequency of leisure activities, frequency of outgoing, social support)
Social function (TMIG Index of Competence)
Participation rate in the program and participants' impressions of the program
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants attend a program for making handicrafts. The classes are held once a week, 2 hours each time, and a total of nine classes in a community space.
Interventions/Control_2
The control group will not do anything during the intervention period. As this is a crossover study, the control group will participate in the intervention program on the second half of the intervention period.
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
60 years and older; ADL-independent; mild cognitive impairment (MMSE>23 & MoCA-J<26); those who sufficiently understand the purpose and content of the research; and who have the ability to agree informed consent.
Key exclusion criteria
Older adults who do not give consent to the research; do not have screening test; cannot come to the community space, and those who are found by medical doctors (co-researchers of this study) to be unable to participate in this program due to significant illness, physical dysfunction, dementia, and other neuropsychological disorders.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerotonlogy
Division name
Research Team for Social Participation and Healthy Aging
Zip code
173-0015
Address
35-2 Sakae-cho,Itabashi-ku, Tokyo, 173-0015,Japan
TEL
03-3964-3241
suzukihy@tmig.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerotonlogy
Division name
Research Team for Social Participation and Healthy Aging
Zip code
173-0015
Address
35-2 Sakae-cho,Itabashi-ku, Tokyo, Japan
TEL
03-3964-3241
Homepage URL
suzukihy@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerotonlogy
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
kouhou@tmghig.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
25re0122007h0003
Org. issuing International ID_1
Japan Agency for Medical Research and Development
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 | 03 | Month | 03 | 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
38
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 03 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065337
