UMIN-CTR Clinical Trial

Basic information
Public title	Mahmudkhani
Acronym	Dr. Mahmudkhani
Scientific Title	EPIDEMIOLOGY OF INJURIES IN MALE WHEELCHAIR BASKETBALL PROFESSIONAL LEAGUE OF IRAN; A REPORT OF FIRST COMPETITION SEASON POST- COVID-19 QUARANTINE
Scientific Title:Acronym	EPIDEMIOLOGY OF INJURIES IN MALE WHEELCHAIR BASKETBALL PROFESSIONAL LEAGUE OF IRAN; A REPORT OF FIRST COMPETITION SEASON POST- COVID-19 QUARANTINE
Region	Asia(except Japan)

Condition
Condition	finished
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to investigate the epidemiology of injuries in the first season of Iran wheelchair basketball Professional league after cov19-quarantine to develop injury prevention literature in para-sport.
Basic objectives2	Others
Basic objectives -Others	epidemiology research
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The findings demonstrate that 77.8% of injuries occurred during training (4.08 per 1000 hours AE (CI 95%: 3.1-4.9).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	injury rate
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	18 years-old <=
Age-upper limit	48 years-old >=
Gender	Male
Key inclusion criteria	All players participating in the first season of the Wheelchair Basketball League after the covid-19 quarantine Individual and informed consent to participate in the research Participate voluntarily and understand research guidelines Attending in team arrange in at least half of the league games
Key exclusion criteria	Reluctance to participate in the research or to withdraw from it Lack of recall of injuries occurred in the training sessions and matches Inadequate cooperation in completing the questionnaire (failure to respond to the details required by researchers)
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Mohammadreza Middle name Last name Mahmoudkhani
Organization	University of Tehran
Division name	Department of Physical Education and Sport Sciences, School of Physical Education and Sport Sciences
Zip code	1474666145
Address	Health and Sport Medicine Department, Physical Education Faculty, University of Tehran, North Kargar Street, Enghelab Sq., Tehran, Iran
TEL	00989125065073
Email	Mahmoudkhani@ut.ac.ir

Public contact
Name of contact person	1st name Mohammadreza Middle name Last name Mahmoudkhani
Organization	University of Tehran
Division name	Department of Physical Education and Sport Sciences, School of Physical Education and Sport Sciences
Zip code	1474666145
Address	Health and Sport Medicine Department, Physical Education Faculty, University of Tehran, North Kargar
TEL	00989125065073
Homepage URL
Email	Mahmoudkhani@ut.ac.ir

Sponsor
Institute	University of Tehran
Institute
Department

Funding Source
Organization	University of Tehran
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	University of Tehran
Address	Health and Sport Medicine Department, Physical Education Faculty, University of Tehran, North Kargar
Tel	00989125065073
Email	Mahmoudkhani@ut.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	2022 Year 04 Month 19 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	36
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	2021 Year 05 Month 01 Day
Date of IRB	2021 Year 06 Month 01 Day
Anticipated trial start date	2021 Year 07 Month 21 Day
Last follow-up date	2021 Year 08 Month 22 Day
Date of closure to data entry	2021 Year 09 Month 22 Day
Date trial data considered complete	2021 Year 10 Month 22 Day
Date analysis concluded	2021 Year 11 Month 22 Day

Other
Other related information

Management information
Registered date	2022 Year 03 Month 05 Day
Last modified on	2022 Year 03 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053716