UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of motor imagery ability related to mental imagery training: Use of a writing task
Acronym	Evaluation of motor imagery ability: Use of a writing task
Scientific Title	Evaluation of motor imagery ability related to mental practice: Use of a writing task
Scientific Title:Acronym	Evaluation of motor imagery ability: Use of a writing task
Region	Japan

Condition
Condition	Stroke patients with upper-extremity disorder
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the measuring tool for motor imagery ability that predicts effectiveness of mental practice on writing
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	writing accuracy after intervention
Key secondary outcomes	time for writing after intervention Kinesthetic and Visual Imagery Questionnaire mental chronometry gordon test

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Subjects receive two training sessions on 2 successive days. Mental Practice group are instructed to imagine themselves writing with observing a writing video from a first-person perspective. Each training session consisted of 10 trials of 1 min. The individual trials were interspersed with rest periods of 30 s. After 5 trials the subjects were allowed to rest for a period of 5 min.
Interventions/Control_2	Subjects receive two training sessions on 2 successive days. Control group are instructed to watch a video which is irrelevant to writing. Each session consisted of 10 trials of 1 min. The individual trials were interspersed with rest periods of 30 s. After 5 trials the subjects were allowed to rest for a period of 5 min.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	healthy students
Key exclusion criteria	They have experience of training to write with non-dominant hand for more than 1 week. They have disorder that they can't write letters in non-dominant hand.
Target sample size	112

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Nagao
Organization	Kobe university graduate school of health sciences
Division name	Rehabilitation science
Zip code	654-0142
Address	7 Chome-10-2, Tomogaoka, Suma, Kobe, Hyogo
TEL	078-796-4570
Email	nagao@kobe-u.ac.jp

Public contact
Name of contact person	1st name Naoya Middle name Last name Okuda
Organization	Kobe university graduate school of health sciences
Division name	master's degree
Zip code	654-0142
Address	7 Chome-10-2, Tomogaoka, Suma, Kobe, Hyogo
TEL	090-1904-6695
Homepage URL
Email	202k207k@stu.kobe-u.ac.jp

Sponsor
Institute	Kobe university
Institute
Department

Funding Source
Organization	Self-funding
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	The ethics committee of Kobe university graduate school of health sciences
Address	7 Chome-10-2, Tomogaoka, Suma, Kobe, Hyogo
Tel	078-796-4502
Email	syomu2@ams.kobe-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	神戸大学保健学研究科(兵庫県)

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 12 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	Preinitiation
Date of protocol fixation	2020 Year 09 Month 15 Day
Date of IRB	2020 Year 11 Month 30 Day
Anticipated trial start date	2021 Year 01 Month 04 Day
Last follow-up date	2021 Year 09 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	2020 Year 12 Month 24 Day
Last modified on	2021 Year 01 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048895

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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