UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040356
Receipt number R000046054
Scientific Title Knee wobbling phenomenon to predict ACL injury risk in young female basketball athletes.
Date of disclosure of the study information 2020/05/11
Last modified on 2023/06/20 10:07:21

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Basic information

Public title

Knee wobbling phenomenon to predict ACL injury risk in young female basketball athletes.

Acronym

Knee wobbling to predict ACL injury

Scientific Title

Knee wobbling phenomenon to predict ACL injury risk in young female basketball athletes.

Scientific Title:Acronym

Knee wobbling to predict ACL injury

Region

Japan


Condition

Condition

Anterior cruciate ligament injury

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To reveal the association between ACL inury and knee wobbling phenomenon

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Knee wobbling phenomenon
ACL injury occurrence

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

12 years-old <=

Age-upper limit

22 years-old >=

Gender

Female

Key inclusion criteria

Healthy joining in sports activity less than 3 days per a week

Key exclusion criteria

previous ACL injury, previous bone fracture of lower extremity, abarticulation, pain during exercises, disability in balance, psychiatric disorder, who has problems with communication and understanding this study

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Kazuyoshi
Middle name
Last name Gamada

Organization

Hiroshima International University

Division name

Graduate School of Medical Technology and Health Welfare Sciences

Zip code

7392695

Address

555-36 Kurosegakuendai Higashihiroshima Hiroshima Japan

TEL

0823704510

Email

kazgamada@ortho-pt.com


Public contact

Name of contact person

1st name Akino
Middle name
Last name Aoki

Organization

Hiroshima International University

Division name

Graduate School of Medical Technology and Health Welfare Sciences

Zip code

7392695

Address

555-36 Kurosegakuendai Higashihiroshima Hiroshima Japan

TEL

0823704510

Homepage URL


Email

aj.spman154@gmail.com


Sponsor or person

Institute

Hiroshima International University

Institute

Department

Personal name



Funding Source

Organization

None

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

Hiroshima International University

Address

555-36 Kurosegakuendai Higashihiroshima Hiroshima Japan

Tel

0823704510

Email

aj.spman154@gmail.com


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 05 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

272

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

No longer recruiting

Date of protocol fixation

2018 Year 08 Month 01 Day

Date of IRB

2018 Year 09 Month 15 Day

Anticipated trial start date

2018 Year 10 Month 01 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

Knee wobbling


Management information

Registered date

2020 Year 05 Month 11 Day

Last modified on

2023 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046054


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name