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 |
* 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
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
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
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
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
