UMIN-CTR Clinical Trial

Basic information
Public title	Acquisition of chopstick-operation skills with the non-dominant hand: Trainig-derived changes in motor skill performance and brain activity pattern.
Acronym	Acquisition of chopstick-operation skills with the non-dominant hand
Scientific Title	Acquisition of chopstick-operation skills with the non-dominant hand
Scientific Title:Acronym	Acquisition of chopstick-operation skills with the non-dominant hand
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate comprehensively whether chopstick training improves non-dominant operation skills
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pre- and post-training results of the speed of motor-execution with non-dominant hand and its change from pre-assessment to post-assessment, and Asymmetric values of the speed of motor-execution with non-dominant and dominant hand and its change from pre-assessment to post-assessment. *Post-training assessment timing sets at the end of 6 week- training.
Key secondary outcomes	1. Pre- and post-training results of the smoothness of upper extremity (root mean square of angular jerk; RMSJ) with non-dominant hand and its change from pre-assessment to post-assessment. 2. Pre- and post-training results of the brain activity (oxygen-hemoglobin concentration; Oxy-Hb concentration) during task performance with non-dominant hand in each channel or regions of interest (ROIs) and its change from pre-assessment to post-assessment. 3. Pre- and post-training results of the brain activity (Oxy-Hb concentration) during task performance with non-dominant hand in each hemisphere and its change from pre-assessment to post-assessment. 4. Pre- and post-training results of the visual analog scale(VAS) as perceived psychological stress with non-dominant hand and its change from pre-assessment to post-assessment. 5. Pre- and post-training results of the speed of motor-execution with dominant hand and its change from pre-assessment to post-assessment. 6. Pre- and post-training results of the smoothness of upper extremity (RMSJ) with dominant hand and its change from pre-assessment to post-assessment. 7. Pre- and post-training results of the brain activity (Oxy-Hb concentration) during task performance with dominant hand in each channel or ROIs and its change from pre-assessment to post-assessment. 8. Pre- and post-training results of the brain activity (Oxy-Hb concentration) during task performance with dominant hand in each hemisphere and its change from pre-assessment to post-assessment. 9. Pre- and post-training results of the VAS as perceived psychological stress with dominant hand and its change from pre-assessment to post-assessment. 10. Asymmetric values of the smoothness of upper extremity (RMSJ) with non-dominant and dominant hand and its change from pre-assessment to post-assessment. 11. Asymmetric values of the VAS as perceived psychological stress w with non-dominant and dominant hand and its change from pre-assessment to post-assessment.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	The training group received 6-week training of the non-dominant hand with chopsticks for 30 min every day, 5 days per week.
Interventions/Control_2	The control group did not receive training.
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	35 years-old >
Gender	Male and Female
Key inclusion criteria	1)Perticipants between 20 and 35 years at the time of the informed consent 2)Right-hander 3)Patients who gave informed consent based on their own will
Key exclusion criteria	1) Participants who have experience using chopsticks with their left non-dominant hand on a daily basis 2)Participants had no history of neurological or psychiatric disorders 3)The researcher judge it difficult for participating in this study
Target sample size	34

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Sawamura
Organization	Hokkaido University
Division name	Faculty of Health Sciences
Zip code	060-0812
Address	Kita12, Nishi5, Kita-ku, Sapporo
TEL	0117063387
Email	D.sawamura@pop.med.hokudai.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Sawamura
Organization	Hokkaido University
Division name	Faculty of Health Sciences
Zip code	060-0812
Address	Kita12, Nishi5, Kita-ku, Sapporo
TEL	0117063387
Homepage URL
Email	D.sawamura@pop.med.hokudai.ac.jp

Sponsor
Institute	Health Sciences University of Hokkaido
Institute
Department

Funding Source
Organization	Health Sciences University of Hokkaido
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	Institutional Review Board of Hokkaido Health Science University
Address	Ishikari-Tobetsu, Hokkaido 061-0293 Japan
Tel	0133-23-1211
Email	kyo-reha@hoku-iryo-u.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

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 22 Day

Related information
URL releasing protocol	https://www.nature.com/articles/s41598-019-56956-0
Publication of results	Partially published

Result
URL related to results and publications	https://www.nature.com/articles/s41598-019-56956-0
Number of participants that the trial has enrolled	34
Results	After 6 week-training, significantly improved chopstick performance were observed in the training group. Moreover, left dorsolateral prefrontal cortex activity significantly decreased, and bilateral premotor cortex activity significantly increased across training. *The results have already been published in the journal. All asymmetric values were significantly lower in the training than in the control group at post-training assessment. *These results will be submitted for publication.
Results date posted	2021 Year 04 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 12 Month 31 Day
Baseline Characteristics	Thirty-four healthy right-handed participants were recruited in this study (17 women; mean age, 21.3(0.7) years) were recruited. Stratified randomization was used to allocate each participant to either the training group or the control group by a researcher who was neither an evaluator nor a trainer.
Participant flow	One participant from the training group failed to complete the program, and one from the control group was unable to accomplish the re-assessment. Thus, 16 participants each were included in the training and control groups.
Adverse events	There were no adverse events.
Outcome measures	1. Pre- and post-training results of the speed of motor-execution with non-dominant hand and its change from pre-assessment to post-assessment, and 2. Pre- and post-training results of the smoothness of upper extremity (root mean square of angular jerk; RMSJ) with non-dominant hand and its change from pre-assessment to post-assessment. 3. Pre- and post-training results of the brain activity (oxygen-hemoglobin concentration; Oxy-Hb concentration) during task performance with non-dominant hand in each channel or regions of interest (ROIs) and its change from pre-assessment to post-assessment. 4. Pre- and post-training results of the brain activity (Oxy-Hb concentration) during task performance with non-dominant hand in each hemisphere and its change from pre-assessment to post-assessment. 5. Pre- and post-training results of the visual analog scale(VAS) as perceived psychological stress with non-dominant hand and its change from pre-assessment to post-assessment. 6. Pre- and post-training results of the speed of motor-execution with dominant hand and its change from pre-assessment to post-assessment. 7. Pre- and post-training results of the smoothness of upper extremity (RMSJ) with dominant hand and its change from pre-assessment to post-assessment. 8. Pre- and post-training results of the brain activity (Oxy-Hb concentration) during task performance with dominant hand in each channel or ROIs and its change from pre-assessment to post-assessment. 9. Pre- and post-training results of the brain activity (Oxy-Hb concentration) during task performance with dominant hand in each hemisphere and its change from pre-assessment to post-assessment. 10. Pre- and post-training results of the VAS as perceived psychological stress with dominant hand and its change from pre-assessment to post-assessment. 11. Asymmetric values of the speed of motor-execution with non-dominant and dominant hand and its change from pre-assessment to post-assessment 12. Asymmetric values of the smoothness of upper extremity (RMSJ) with non-dominant and dominant hand and its change from pre-assessment to post-assessment. 13. Asymmetric values of the VAS as perceived psychological stress w with non-dominant and dominant hand and its change from pre-assessment to post-assessment.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 29 Day
Date of IRB	2016 Year 07 Month 29 Day
Anticipated trial start date	2016 Year 08 Month 31 Day
Last follow-up date	2017 Year 08 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	2021 Year 04 Month 21 Day
Last modified on	2021 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050241