UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022090 |
|---|---|
| Receipt number | R000025440 |
| Scientific Title | The study of influences of shoulder sling on body functions and wearing feel. |
| Date of disclosure of the study information | 2016/04/27 |
| Last modified on | 2018/02/27 22:35:48 |
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Basic information
Public title
The study of influences of shoulder sling on body functions and wearing feel.
Acronym
The study of shoulder sling.
Scientific Title
The study of influences of shoulder sling on body functions and wearing feel.
Scientific Title:Acronym
The study of shoulder sling.
Region
| Japan |
Condition
Condition
Rotater Cuff Injury
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)To investigate shoulder muscle tone, body alignment, body function with shoulder sling during rest and activity of daily living
2)To investigate the wearing feel and simplicity, stability, pain, and sleep with questionnaire survey
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The tension of shoulder muscle
Key secondary outcomes
Questionnaire survey
Basic information:Age, Height, Body weight, Sex
Medical information:disease, size and part of tear, radiographic image, pain
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearing shoulder sling Type A-B-A
One group wear sling A for 2 weeks after surgery, and sling B for 4 days, and sling A for 4 days.
Interventions/Control_2
Wearing shoulder sling Type B-A-B
Other group wear sling B for 2 weeks after surgery, and sling A for 4 days, and sling B for 4 days.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
abc
Key exclusion criteria
1.People who had physical dysfunctions that may influence outcome measures, such as neurological impairment and musculoskeletal impairment except spine and shoulder disease.
2.People who have stand and gait disorder from neurological and internal medical disease.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki Ichihashi |
Organization
Kyoto University
Division name
Human Health Sciences, Graduate School of Medicine
Zip code
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3951
ichihashi.noriaki.5z@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriaki Ichihashi |
Organization
Kyoto University
Division name
Human Health Sciences, Graduate School of Medicine
Zip code
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3951
Homepage URL
ichihashi.noriaki.5z@kyoto-u.ac.jp
Sponsor or person
Institute
Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
ALCARE INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
ALCARE INC.
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | 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
| 2016 | Year | 04 | Month | 27 | Day |
Last modified on
| 2018 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025440
