UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of influences of shoulder sling on body functions and wearing feel.
Title of the study (Brief title)	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	Noriaki Ichihashi
Organization	Kyoto University
Division name	Human Health Sciences, Graduate School of Medicine
Address	53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-3951
Email	ichihashi.noriaki.5z@kyoto-u.ac.jp

Public contact
Name of contact person	Noriaki Ichihashi
Organization	Kyoto University
Division name	Human Health Sciences, Graduate School of Medicine
Address	53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-3951
Homepage URL
Email	ichihashi.noriaki.5z@kyoto-u.ac.jp

Sponsor
Institute	Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025440