UMIN-CTR Clinical Trial

Basic information
Public title	Changes in resting-state functional connectivity after motor learning of chopstick manipulation with the non-dominant hand
Acronym	Changes in resting-state functional connectivity after motor learning of chopstick manipulation with the non-dominant hand
Scientific Title	Changes in resting-state functional connectivity after motor learning of chopstick manipulation with the non-dominant hand
Scientific Title:Acronym	Changes in resting-state functional connectivity after motor learning of chopstick manipulation with the non-dominant hand
Region	Japan

Condition
Condition	right-handed healthy subjects
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the changes in resting-state functional connectivity in right-handed healthy subjects after short-term chopstick manipulation motor learning with the non-dominant hand.
Basic objectives2	Others
Basic objectives -Others	We will clarify the neural mechanisms of short-term motor learning of chopstick manipulation and provide new insights for non-dominant hand training in rehabilitation situations.
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, eye movements (number of times and duration of gazing)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
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	1.intervention group: - 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	2.control group: - Repeat 9 sets of 30-second chopstick manipulation task and 30-second rest. - Chopstick manipulation task: Perform the task of only holding the chopsticks with the left hand (maintaining the shape of the operation) (control 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	20 years-old <=
Age-upper limit	45 years-old >=
Gender	Male and Female
Key inclusion criteria	- Healthy individuals between the ages of 20 and 45. - 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.
Target sample size	45

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
Email	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
Email	takeda-sayori1@ed.tmu.ac.jp

Sponsor
Institute	Graduate School of Human Health Sciences, Tokyo Metropolitan University
Institute
Department

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
Email	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	2021 Year 09 Month 28 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	Completed
Date of protocol fixation	2021 Year 06 Month 13 Day
Date of IRB	2021 Year 09 Month 02 Day
Anticipated trial start date	2021 Year 09 Month 04 Day
Last follow-up date	2022 Year 04 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	2021 Year 09 Month 10 Day
Last modified on	2022 Year 12 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051817