UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055642 |
|---|---|
| Receipt number | R000063590 |
| Scientific Title | Evaluation of a hand sensorimotor stimulation intervention study to prevent cognitive decline: An exploratory study for community-dwelling older adults with mild cognitive impairment. |
| Date of disclosure of the study information | 2024/09/27 |
| Last modified on | 2025/10/15 12:16:59 |
* 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
Evaluation of a hand sensorimotor stimulation program to prevent cognitive decline
Acronym
Effect of a hand sensorimotor program
Scientific Title
Evaluation of a hand sensorimotor stimulation intervention study to prevent cognitive decline: An exploratory study for community-dwelling older adults with mild cognitive impairment.
Scientific Title:Acronym
Effect of a hand sensorimotor program
Region
| Japan |
Condition
Condition
Community-dwelling older adults with mild cognitive impairment
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of a combined tactile sensory and manual dexterity intervention program on cognitive function, hand sensorimotor function, mental health, social functioning, and cost effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
Executive function, Processing speed
Key secondary outcomes
Processing speed
Cognitive test battery
Hand motor function
Hand sensory function
Instrumental Activities of Daily Living
Self-rated health
Quality of life
Depressive symptoms
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
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 combined tactile stimulation (sensory ball and finger maze sensory mat) and hand dexterity program (3D puzzles, 3D origami, paper crumpling activity) lectured by instructors. The classes are held once a week, 1 hour each time, and a total of 3 months in a community space.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
65 years and older; ADL-independent; mild cognitive impairment; 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 cannot come to the community space; 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 neuropsychological disorders etc.
Target sample size
11
Research contact person
Name of lead principal investigator
| 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 Building 3-9-7 Itabashi, Itabashi-ku, Tokyo 173-0004, JAPAN
TEL
03-6905-6781
kimiestela@hotmail.com
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 Building 3-9-7 Itabashi, Itabashi-ku, Tokyo 173-0004, 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
Funding Source
Organization
MEXT (Grants-in-Aid for Scientific Research)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
aiizuka@tmig.or.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
| 2024 | Year | 09 | Month | 27 | 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
11
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
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 02 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 02 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preliminary findings on the feasibility and acceptability of this intervention study will be presented in a symposium at IAGG 2026.
Management information
Registered date
| 2024 | Year | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063590
