UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042834
Receipt number R000048895
Scientific Title Evaluation of motor imagery ability related to mental practice: Use of a writing task
Date of disclosure of the study information 2021/01/12
Last modified on 2021/06/27 09:47:02

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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 or person

Institute

Kobe university

Institute

Department

Personal name



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

39

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

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 06 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048895