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
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
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
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
