UMIN-CTR Clinical Trial

Basic information
Public title	Physical function, balance function and musculoskeletal injuries in Ballet dancers
Acronym	Physical function, balance function and musculoskeletal injuries in Ballet dancers
Scientific Title	Physical function, balance function and musculoskeletal injuries in Ballet dancers
Scientific Title:Acronym	Physical function, balance function and musculoskeletal injuries in Ballet dancers
Region	Japan

Condition
Condition	musculoskeletal injuries
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify these physical characteristics and musculoskeletal injuries in ballet dancers.
Basic objectives2	Others
Basic objectives -Others	non
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Methods: Classic ballet dancers, aged 15 to 22 years old, were recruited from ballet school. We assessed toe flexor, ankle dorsi-flexor and ankle plantar-flexor muscle strength with dynamometer. ROM of hip, knee and ankle were measured. Foot arch height was assessed as the distance between the navicular tuberosity of the foot and the floor. Balance function was tested with Y balance test. The path of the center of pressure (COP) was measure with motion analysis of two static ballet posture and three type of ballet jumps. We assessed the physical conditions with using questionnaires about history of ballet, sports injury, and amenorrhea.
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	22 years-old >=
Gender	Female
Key inclusion criteria	Regular ballet training.
Key exclusion criteria	Quitting ballet. Judged to be inappropriate as research subjects.(When it is judged that there are circumstances such as diseases that cannot safely perform the inspection items)
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Toshiyuki Middle name Last name Fujiwara
Organization	Juntendo university
Division name	rehabilitation medicine
Zip code	113-0034
Address	1-5-29-702,Yushima,Bunkyouku,Tokyo
TEL	03-3813-3111
Email	t-fuijwara@juntendo.ac.jp

Public contact
Name of contact person	1st name MOMOKO Middle name Last name OMI
Organization	Juntendo university
Division name	rehabilitation medicine
Zip code	113-0034
Address	1-5-29-702,Yushima,Bunkyouku,Tokyo
TEL	03-3813-3111
Homepage URL
Email	mo-omi@juntendo.ac.jp

Sponsor
Institute	Juntendo university
Institute
Department

Funding Source
Organization	Juntendo university
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	Juntendo university
Address	1-5-29-702,Yushima,Bunkyouku,Tokyo
Tel	03-3813-3111
Email	mo-omi@juntendo.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	順天堂大学

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 02 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	Open public recruiting
Date of protocol fixation	2020 Year 12 Month 15 Day
Date of IRB	2020 Year 12 Month 15 Day
Anticipated trial start date	2020 Year 12 Month 15 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	non

Management information
Registered date	2021 Year 02 Month 02 Day
Last modified on	2021 Year 02 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049309