UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025602 |
|---|---|
| Receipt number | R000029449 |
| Scientific Title | A study on the effect of massage device on elasticity and muscle hardness of neck, trunk and lower limb muscle |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2019/07/14 11:56:44 |
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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
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
norimmi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029449
