UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036160
Receipt number R000041162
Scientific Title The effect of difference in cognitive loading amount of antagonism exercises on event related potential P300
Date of disclosure of the study information 2019/03/11
Last modified on 2022/03/15 17:20:24

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Basic information

Public title

The effect of difference in cognitive loading amount of antagonism exercises on event related potential P300

Acronym

The effect of difference in cognitive loading amount of antagonism exercises on event related potential P300

Scientific Title

The effect of difference in cognitive loading amount of antagonism exercises on event related potential P300

Scientific Title:Acronym

The effect of difference in cognitive loading amount of antagonism exercises on event related potential P300

Region

Japan


Condition

Condition

healthy subject

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify the cognitive load of antagonistic exercises using event related potential P300

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Amplitude of P300

Key secondary outcomes

Latency of P300
Reaction time to Odd-ball task
Number of correct responses to Odd-ball task
Number of errors in antagonism exercises
Subjective difficulty index


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

antagonistic exercise (Complex task) and Odd ball task

Interventions/Control_2

antagonistic exercise (Simple task) and Odd ball task

Interventions/Control_3

Odd ball task

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Person with the exercise capacity that can conduct a problem
Age is a person 20 years or older at the person agreement acquisition with the exercise capacity that can conduct a problem
The person that the agreement of the study was obtained

Key exclusion criteria

A person with a history of the disease of the central nerve disorder
A person who have skin rash with alcohol

Target sample size

31


Research contact person

Name of lead principal investigator

1st name akira
Middle name
Last name sagari

Organization

Shinshu University

Division name

Division of Occupational Therapy School of Health Science

Zip code

3900861

Address

3-1-1 Asahi, Matsumoto, Nagano 390-8621 JAPAN

TEL

09079247401

Email

sagaria@shinshu-u.ac.jp


Public contact

Name of contact person

1st name akira
Middle name
Last name sagari

Organization

Shinshu University

Division name

Division of Occupational Therapy School of Health Science

Zip code

3900861

Address

3-1-1 Asahi, Matsumoto, Nagano 390-8621 JAPAN

TEL

0263372404

Homepage URL


Email

sagaria@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University

Institute

Department

Personal name



Funding Source

Organization

Shinshu University

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

Shinshu University School of Medicine Ethics Review Board

Address

3-1-1 Asahi, Matsumoto, Nagano 390-8621 JAPAN

Tel

0263372572

Email

mdrinri@shinshu-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

2019 Year 03 Month 11 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

29

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 05 Day

Date of IRB

2019 Year 03 Month 06 Day

Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2021 Year 03 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

2019 Year 03 Month 11 Day

Last modified on

2022 Year 03 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041162


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name