UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000036222
Receipt number R000041263
Scientific Title Effect of the Motor Imagery with Virtual Reality on prosthetic operability.
Date of disclosure of the study information 2019/04/17
Last modified on 2020/03/20 04:02:10

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Basic information

Public title

Effect of the Motor Imagery with Virtual Reality on prosthetic operability.

Acronym

Effect of the Motor Imagery with Virtual Reality on prosthetic operability.

Scientific Title

Effect of the Motor Imagery with Virtual Reality on prosthetic operability.

Scientific Title:Acronym

Effect of the Motor Imagery with Virtual Reality on prosthetic operability.

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effect of motor imagery with VR on prosthetic operability.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The prosthetic operability is evaluated by the score of Box and Block test, tie knot task, accelerometer.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Control.

Interventions/Control_2

Perform motor imagery for 10 minutes with VR animation of the first person perspective.

Interventions/Control_3

Perform motor imagery for 10 minutes with VR animation of the third person perspective..

Interventions/Control_4

Perform motor imagery for 10 minutes with a tablet terminal animation of the third person perspective.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Healthy adult who was offered to participate in this research by a poster for recruitment of research participants.
2.Right handed in Edinburgh handedness test.

Key exclusion criteria

1. Persons with a history of neurological disorder or merger

Target sample size

49


Research contact person

Name of lead principal investigator

1st name Manabu
Middle name
Last name Yoshimura

Organization

Hiroshima University Graduate School of Biomedical & Health Sciences

Division name

Laboratory of analysis & control of upper extremity function

Zip code

734-0037

Address

1-2-3Kasumi,Minami-ku,Hiroshima

TEL

082-257-5455

Email

d180255@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Manabu
Middle name
Last name Yoshimura

Organization

Hiroshima University Graduate School of Biomedical & Health Sciences

Division name

Laboratory of analysis & control of upper extremity function

Zip code

734-0037

Address

1-2-3Kasumi,Minami-ku,Hiroshima

TEL

082-257-5455

Homepage URL


Email

d180255@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima university

Institute

Department

Personal name



Funding Source

Organization

The KAWASAKI Foundation for Medical Science and Medical Welfare

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kawasaki medical scool

Address

577 matsushima, Kurashikishi ,Okayama

Tel

086-462-1111

Email

kmsrec@med.kawasaki-m.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

川崎医科大学附属病院


Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 17 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

2019 Year 03 Month 16 Day

Date of IRB

2019 Year 06 Month 11 Day

Anticipated trial start date

2019 Year 04 Month 17 Day

Last follow-up date

2020 Year 04 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 03 Month 16 Day

Last modified on

2020 Year 03 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041263


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name