UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028090
Receipt No. 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 2019/07/07

* 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 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
2021 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
2019 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.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


Contact us.