UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030048 |
|---|---|
| Receipt number | R000034313 |
| Scientific Title | efficacy of exercise shoulder brace for preventing contracture |
| Date of disclosure of the study information | 2017/11/20 |
| Last modified on | 2018/11/22 15:52:02 |
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Basic information
Public title
efficacy of exercise shoulder brace for preventing contracture
Acronym
efficacy of exercise shoulder brace
Scientific Title
efficacy of exercise shoulder brace for preventing contracture
Scientific Title:Acronym
efficacy of exercise shoulder brace
Region
| Japan |
Condition
Condition
normal volunteers
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze the efficacy of new exercise shoulder brace
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the angle rotation of humeral and scapula
Key secondary outcomes
the position of the center of humeral head
alignment of the spine
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
| Device,equipment |
Interventions/Control_1
The volunteers are requested to equip shoulder brace for 30 minutes and to conduct MRI.
Interventions/Control_2
More than 1 week later, they are also requested to equip new shoulder brace for 30 minutes and to conduct MRI again.
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy normal person
Key exclusion criteria
person who have disability in shoulder
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Hagiwara |
Organization
Tohoku university
Division name
Department of orthopaedic surgery
Zip code
Address
1-1, Seiryomachi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7248
hagi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Hagiwara |
Organization
Tohoku university
Division name
Department of orthopaedic surgery
Zip code
Address
1-1, Seiryomachi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7248
Homepage URL
hagi@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Tohoku university Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Tohoku university Graduate School of Medicine
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 11 | Month | 20 | 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
| 2017 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | 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
| 2017 | Year | 11 | Month | 20 | Day |
Last modified on
| 2018 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034313
