UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028090
Receipt number R000032153
Scientific Title Relationship between return to sports and the personality test results in patients after anterior cruciate ligament reconstruction
Date of disclosure of the study information 2017/07/07
Last modified on 2021/01/06 11:42:55

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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 or person

Institute

keio university

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032153


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name