UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043231
Receipt number R000049309
Scientific Title Physical function, balance function and musculoskeletal injuries in Ballet dancers
Date of disclosure of the study information 2021/02/02
Last modified on 2021/02/02 17:14:45

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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 or person

Institute

Juntendo university

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049309


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name