UMIN-CTR Clinical Trial

Basic information
Public title	Mechanisms of Yips in athletes
Acronym	Mechanisms of Yips
Scientific Title	A study on the neurophysiological mechanisms of Yips in athletes
Scientific Title:Acronym	Neurophysiological mechanisms of Yips
Region	Japan

Condition
Condition	Yips in athletes
Classification by specialty	Neurology Psychiatry Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To understand neurophysiological mechanisms of Yips
Basic objectives2	Others
Basic objectives -Others	To compare neurophysiological measures between athletes with yips and control
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EEG and force control ability
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	50 years-old >
Gender	Male and Female
Key inclusion criteria	Athletes with yip and physically active individuals
Key exclusion criteria	Individuals with severe orthopedic disease, cardiopulmonary disease, psychiatric disorders, cognitive disorders, or visual disorders that cannot be corrected with glasses, and those taking psychotropic drugs
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hideshi Middle name Last name Sugiura
Organization	Nagoya University
Division name	Graduate School of Medicine
Zip code	461-8673
Address	1-1-20 Daiko-minami, Higashi-ku, Nagoya
TEL	052-719-1364
Email	hsugiura@met.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Hideshi Middle name Last name Sugiura
Organization	Nagoya University
Division name	Graduate School of Medicine
Zip code	461-8673
Address	1-1-20 Daiko-minami, Higashi-ku, Nagoya
TEL	052-719-1364
Homepage URL
Email	hsugiura@met.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Mizuno Sports Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	Havana Trainers Room
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya University Graduate School of Medicine
Address	1-1-20 Daiko-minami, Higashi-ku, Nagoya
Tel	052-719-1504
Email	saito.kaori@adm.nagoya-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	2020 Year 10 Month 10 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	20
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 05 Month 10 Day
Date of IRB	2019 Year 07 Month 12 Day
Anticipated trial start date	2019 Year 09 Month 15 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Subject sits on a chair in front of a table on which a PC monitor is placed. The subject is asked to produce a lateral pinch force and match the force to a target shown on the PC monitor. During the task, electroencephalography and force produced by the subject are recorded.

Management information
Registered date	2020 Year 10 Month 09 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047999