UMIN-CTR Clinical Trial

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
Email	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
Email	smaniwa@med.shimane-u.ac.jp

Sponsor
Institute	Department of Rehabilitation Medicine Shimane University Faculty of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044049