UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between return to sports and the personality test results in patients after anterior cruciate ligament reconstruction
Acronym	Relationship between return to sports and the personality test results in patients after anterior cruciate ligament reconstruction
Scientific Title	Relationship between return to sports and the personality test results in patients after anterior cruciate ligament reconstruction
Scientific Title:Acronym	Relationship between return to sports and the personality test results in patients after anterior cruciate ligament reconstruction
Region	Japan

Condition
Condition	patients after anterior cruciate ligament reconstruction
Classification by specialty	Psychiatry Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	relationship between personality traits and return to sports
Basic objectives2	Others
Basic objectives -Others	relationship other psychological tests outcomes and return to sports
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Psychological test of Neo PI-R
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	15 years-old <=
Age-upper limit	45 years-old >=
Gender	Male and Female
Key inclusion criteria	patients after anterior cruciate ligament reconstruction who injured in sports
Key exclusion criteria	1. Cerebral infarction, brain tumor and other organic brain diseases that cause mental symptoms 2. When you have diagnosed mental disorders such as depression, schizophrenia etc. within the past year 3. Taking psychotropic drugs (antidepressants, antipsychotic drugs, tranquilizers, etc.) currently or in the past 4 weeks When 4. When taking some investigational medicine in the first month before screening 5. Participating in clinical research or investigational drug trials other than this research 6. When the anterior cruciate ligament is re-torn and performing reconstruction 7. Crohn's disease, Castleman's disease and other inflammatory diseases
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hajime Middle name Last name Tabuchi
Organization	keio university school of medicine
Division name	Department of Neuropsychiatry
Zip code	1608582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3971
Email	tabuchi@a8.keio.jp

Public contact
Name of contact person	1st name Tatsuya Middle name Last name Yamaguchi
Organization	keio university school of medicine
Division name	Department of Neuropsychiatry
Zip code	1608582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3971
Homepage URL
Email	tatsuyamaguchi@keio.jp

Sponsor
Institute	keio university
Institute
Department

Funding Source
Organization	keio university
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	Ethics Committee of keio university school of medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel	0333531211
Email	med-rinri-jimu@adst.keio.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	2017 Year 07 Month 07 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	Enrolling by invitation
Date of protocol fixation	2017 Year 05 Month 08 Day
Date of IRB	2016 Year 09 Month 26 Day
Anticipated trial start date	2017 Year 07 Month 17 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational research, cross-sectional prospective study

Management information
Registered date	2017 Year 07 Month 05 Day
Last modified on	2021 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032153