UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049679 |
|---|---|
| Receipt number | R000056583 |
| Scientific Title | Differences in brain network changes due to motor learning in older and younger adults |
| Date of disclosure of the study information | 2023/01/13 |
| Last modified on | 2023/12/05 05:41:50 |
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Basic information
Public title
Differences in brain network changes due to motor learning in older and younger adults
Acronym
Differences in brain network changes due to motor learning in older and younger adults
Scientific Title
Differences in brain network changes due to motor learning in older and younger adults
Scientific Title:Acronym
Differences in brain network changes due to motor learning in older and younger adults
Region
| Japan |
Condition
Condition
right-handed healthy subjects (young adults, older adults)
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the differences in changes in resting-state functional connectivity (RSFC) between older and younger adults during short-term chopsticks operation motor learning with the nondominant hand.
Basic objectives2
Others
Basic objectives -Others
To clarify the differences between older and younger adults in the neural mechanisms of short-term motor learning of chopsticks operation, and to provide new insights into non-dominant hand training in rehabilitation settings.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resting state functional connectivity strength (fMRI data) before and after 9 minutes of chopstick manipulation motor learning.
Key secondary outcomes
Number of items moved with chopsticks, subjective sense of difficulty/fatigue
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
In young adults
- Repeat 9 sets of 30-second chopstick manipulation task and 30-second rest.
- Chopstick manipulation task:
Perform the task of picking up and moving objects using chopsticks with the left hand (practice task).
Interventions/Control_2
in older adults
- Repeat 9 sets of 30-second chopstick manipulation task and 30-second rest.
- Chopstick manipulation task:
Perform the task of picking up and moving objects using chopsticks with the left hand (practice task).
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Healthy adult male and female
- Young group: 18 to 40 years old
- Older group: 65 to 80 years old
- To eliminate the effects of the dominant cerebral hemisphere, only a right-handed person participates.
Key exclusion criteria
- A person who have experienced actively using chopsticks with the left hand.
- A person who is taking medication acting on the central nervous system.
- Persons not eligible for MRI imaging.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sayori |
| Middle name | |
| Last name | Takeda |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL
09053542654
takeda-sayori1@ed.tmu.ac.jp
Public contact
Name of contact person
| 1st name | Sayori |
| Middle name | |
| Last name | Takeda |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL
09053542654
Homepage URL
takeda-sayori1@ed.tmu.ac.jp
Sponsor or person
Institute
Graduate School of Human Health Sciences,
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan University
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
Tel
03-3819-1211
rinri-hs@tmu.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
東京都立大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2022 | Year | 12 | Month | 02 | Day |
Last modified on
| 2023 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056583
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
