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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032907
Receipt No. R000037319
Scientific Title A study of the single leg jump movement to the front of the person with valgus of the subtalar joint
Date of disclosure of the study information 2018/08/01
Last modified on 2018/12/08

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Basic information
Public title A study of the single leg jump movement to the front of the person with valgus of the subtalar joint
Acronym A study of the single leg jump movement to the front of the person with valgus of the subtalar joint
Scientific Title A study of the single leg jump movement to the front of the person with valgus of the subtalar joint
Scientific Title:Acronym A study of the single leg jump movement to the front of the person with valgus of the subtalar joint
Region
Japan

Condition
Condition Valgus of the subtalar joint
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to clarify the characteristic of the movement of a human trunk and lower limbs with the valgus of the subtalra joint in the single leg jump
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Outcome of Alignment
1.Leg-heel alignment when jumping
2.Trunk anterior tilt angle and lateral tilt angle when jyumping
3.Rotation angle of the lower leg when jumping


Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Stand with one leg to the subject with valgus of the subtalar joint, jumping forward and landing on the the same foot.Divide the distance into 5 times(10cm,20cm,30cm,40cm,Max) and let them jump.
Interventions/Control_2 Stand with one leg to the subject without valgus of the subtalar joint, jumping forward and landing on the the same foot.Divide the distance into 5 times(10cm,20cm,30cm,40cm,Max) and let them jump.
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
20 years-old <=
Age-upper limit
29 years-old >=
Gender Male and Female
Key inclusion criteria Healthy normal person
Key exclusion criteria Those with Hospital care for any disease
Those with hallux valgus
Those who has history of operation in lower extremity disease in the past
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Ohno
Organization Osaka University
Division name Graduate School of Medicine
Zip code
Address 1-7 Yamadaoka, Suita, Osaka
TEL 06-6879-2522
Email ohno@sahs.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinsuke Okubo
Organization Osaka University
Division name Graduate School of Medicine
Zip code
Address 1-7 Yamadaoka, Suita, Osaka
TEL 06-6879-2526
Homepage URL
Email 25b17003@sahs.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka University of Human Sciences
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 07 Day
Last modified on
2018 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037319

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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