UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038685 |
|---|---|
| Receipt number | R000044049 |
| Scientific Title | Influence of spine movement on scapula position and scapula muscle activity when wearing a shoulder immobilizer. |
| Date of disclosure of the study information | 2019/11/25 |
| Last modified on | 2021/05/27 13:17:59 |
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Basic information
Public title
Influence of spine movement on scapula muscle activity when wearing a shoulder immobilizer.
Acronym
Spine movement and scapula muscle activity when wearing a shoulder immobilizer.
Scientific Title
Influence of spine movement on scapula position and scapula muscle activity when wearing a shoulder immobilizer.
Scientific Title:Acronym
Spine movement and scapula muscle activity when wearing a shoulder immobilizer.
Region
| Japan |
Condition
Condition
rotator cuff injury of the shoulder
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of spine movement on scapular muscle activity when wearing a shoulder immobilizer.
Basic objectives2
Others
Basic objectives -Others
To study the effect of spine movement on repaired rotator cuff tendons when wearing a shoulder immobilizer.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
EMG of scapular muscles
(supraspinatus m., infraspinatusu m., trapezius m.)
Key secondary outcomes
position of scapula (using a measure)
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
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
In healthy condition.
Right handed
Bilateral shoulder flection is more than 170 degrees
Bilateral shoulder abduction is more than 170 degrees.
Key exclusion criteria
Right shoulder pain
Past history of trauma in right shoulder
Past history of trauma in cervical spine
Shoulder instability
Scoliosis of the spine
Funnel chest
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Sokichi |
| Middle name | |
| Last name | Maniwa |
Organization
Shimane University Faculty of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2457
smaniwa@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Sokichi |
| Middle name | |
| Last name | Maniwa |
Organization
Shimane University Faculty of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2457
Homepage URL
smaniwa@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine
Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Rehabilitation Medicine
Shimane University faculty of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Shimane University faculty of Medicine
Address
89-1 Enya-cho, Izumo, Shimane
Tel
0853-23-2111
mga-kikaku@office.shimane-u.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
島根大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 25 | 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
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Startup meeting: November 13, 2019
Management information
Registered date
| 2019 | Year | 11 | Month | 25 | Day |
Last modified on
| 2021 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044049
