UMIN-CTR Clinical Trial

Basic information
Public title	A study on the effect of massage device on elasticity and muscle hardness of neck, trunk and lower limb muscle
Acronym	A study on the effect of massage device on msucle elasticity and hardness
Scientific Title	A study on the effect of massage device on elasticity and muscle hardness of neck, trunk and lower limb muscle
Scientific Title:Acronym	A study on the effect of massage device on msucle elasticity and hardness
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the effect of massage device on elasticity and muscle hardness of neck, trunk and lower limb muscle.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)Distortion rate of tissue to compression operation of each target muscle 2)Insertion distance of probe by muscle hardness tester
Key secondary outcomes	Visual Analogue scale

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	We confirm the effect on muscle elasticity and hardness on the target muscle (trapezius, Rhomboid, erector spinae, Triceps surae muscle, etc.) for 5 minutes before and after using the massage device.
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	30 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Healthy men and women aged 20 to 30 2)Hiroshima University students who understand the contents and obtained written consent to participate in this study
Key exclusion criteria	1)Those who have a history of surgery on the neck, trunk and lower limbs 2)This researcher and subjects are in the relationship between teacher and student 3)The student has interests with the person in charge 4)Those who are deemed inappropriate by the Research Director or Research Assignee
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Yukio Middle name Last name Urabe
Organization	Graduate School of Biomedical & Health Sciences
Division name	Division of Sport Rehabilitation
Zip code	734-8553
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL	082-257-5405
Email	norimmi@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Noriaki Middle name Last name Maeda
Organization	Graduate School of Biomedical & Health Sciences
Division name	Division of Sport Rehabilitation
Zip code	734-8553
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL	082-257-5406
Homepage URL
Email	norimmi@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	Dream Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Graduate School of Biomedical & Health Sciences
Address	1-2-3 Kasumi, Minamiku, Hiroshima, Japan
Tel	082-257-5410
Email	norimmi@hiroshima-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

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 01 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	7
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	2017 Year 01 Month 31 Day
Date of IRB	2017 Year 12 Month 21 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2019 Year 07 Month 01 Day
Date of closure to data entry	2019 Year 07 Month 12 Day
Date trial data considered complete
Date analysis concluded	2017 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2017 Year 01 Month 10 Day
Last modified on	2019 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029449