UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044007 |
|---|---|
| Receipt number | R000050241 |
| Scientific Title | Acquisition of chopstick-operation skills with the non-dominant hand |
| Date of disclosure of the study information | 2021/04/22 |
| Last modified on | 2021/04/21 20:18:07 |
* 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
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
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
D.sawamura@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Health Sciences University of Hokkaido
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050241
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
