UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in muscle hardness of the shoulder stiffness and shoulder joint muscle in the same sitting posture using cervical spinal brace
Title of the study (Brief title)	Changes in muscle hardness of the shoulder stiffness and shoulder joint muscle in the same sitting posture using cervical spinal brace
Region	Japan

Condition
Condition	Healthy person
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of usefulness
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Muscle hardness
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Cervical brace
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	18 years-old <=
Age-upper limit	23 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy person
Key exclusion criteria	Persons with disabilities
Target sample size	20

Research contact person
Name of lead principal investigator	Hirokazu Haruna
Organization	Hokkaido University of Science
Division name	Faculty of Health Science
Address	7-15-4-1 Maeda,Teine,Sapporo,hokkaido,japan
TEL	011-668-2204
Email	haruna@hus.ac.jp

Public contact
Name of contact person	Hirokazu Haruna
Organization	Hokkaido University of Science
Division name	Faculty of Health Science
Address	7-15-4-1 Maeda,Teine,Sapporo,hokkaido,japan
TEL	011-668-2204
Homepage URL
Email	haruna@hus.ac.jp

Sponsor
Institute	Hokkaido University of Science
Institute
Department

Funding Source
Organization	Hokkaido University of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 25 Day
Anticipated trial start date	2018 Year 02 Month 25 Day
Last follow-up date	2019 Year 02 Month 26 Day
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	2018 Year 02 Month 25 Day
Last modified on	2019 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035920