UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050048
Receipt number R000057019
Scientific Title Effects of FIFA 11 warm up program on kinematics and proprioception in adolescent male and female soccer players a parallel group randomized control trial
Date of disclosure of the study information 2023/01/24
Last modified on 2023/01/24 14:56:32

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Basic information

Public title

Effects of FIFA 11 warm up program on kinematics and proprioception in adolescent male and female soccer players a parallel group randomized control trial

Acronym

FIFA 11 warm up, soccer players, kinematics, soccer injuries

Scientific Title

Effects of FIFA 11 warm up program on kinematics and proprioception in adolescent male and female soccer players a parallel group randomized control trial

Scientific Title:Acronym

Effects of FIFA 11 warm-up program on kinematics and proprioception in adolescent male and female soccer players a parallel group randomized control trial

Region

Asia(except Japan)


Condition

Condition

parallel-group randomized controlled trial

Classification by specialty

Medicine in general Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

this study aims to investigate the effects of the 11+ warm-up injury prevention program on kinematics in adolescent male and female soccer players; in a randomized control trial.

Basic objectives2

Others

Basic objectives -Others

this study aims to investigate the effects of the 11+ warm-up injury prevention program on JPS in adolescent male and female soccer players; in a randomized control trial.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

kinematics variable

Key secondary outcomes

Joint Position Sense (Proprioception)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

The FIFA 11 warm up program

Interventions/Control_2

control

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

14 years-old <=

Age-upper limit

16 years-old >=

Gender

Male and Female

Key inclusion criteria

age ranged from 14 to 16 years old
experienced at least 3 years regular soccer experiences playing soccer

Key exclusion criteria

joint laxity (examining the individual Beaton index), neurological, no history of the trunk or lower limb surgery, fractures, joint replacements of the lower extremity.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Mohammadreza
Middle name
Last name Seyedi

Organization

Sport Sciences Research Institute Tehran Iran

Division name

Department of Sports Injuries and Corrective Exercises

Zip code

1587958711

Address

No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.

TEL

+982188747884

Email

seyedi@ssrc.ac.ir


Public contact

Name of contact person

1st name Esmaeil
Middle name
Last name Mozafaripour

Organization

Tehran university

Division name

faculty of sport science

Zip code

1587958711

Address

Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehra

TEL

+989192787818

Homepage URL


Email

e.mozafaripour@yahoo.com


Sponsor or person

Institute

Sport Sciences Research Institute

Institute

Department

Personal name



Funding Source

Organization

no funding

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

Sport Sciences Research Institute

Address

No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.

Tel

+982188747884

Email

ssrc.intoffice@ssrc.ac.ir


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

2023 Year 01 Month 24 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

40

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

Terminated

Date of protocol fixation

2022 Year 04 Month 08 Day

Date of IRB

2021 Year 12 Month 03 Day

Anticipated trial start date

2022 Year 06 Month 01 Day

Last follow-up date

2022 Year 08 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2023 Year 01 Month 16 Day

Last modified on

2023 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057019


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name