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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013096
Receipt No. R000015279
Scientific Title The effect of electrical muscle stimulation in the infraspinatus muscle
Date of disclosure of the study information 2014/02/06
Last modified on 2014/02/06

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Basic information
Public title The effect of electrical muscle stimulation in the infraspinatus muscle
Acronym The effect of electrical muscle stimulation in the infraspinatus muscle
Scientific Title The effect of electrical muscle stimulation in the infraspinatus muscle
Scientific Title:Acronym The effect of electrical muscle stimulation in the infraspinatus muscle
Region
Japan

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

Objectives
Narrative objectives1 We examine the effects of muscular hypertrophy and strength caused by electrical muscle stimulation(EMS) in the infraspinatus of healthy people
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference in changes in the thickness of infraspinatus muscle and strength of shoulder external rotation before and after the intervention from training group to control group
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 We perform electrical muscle stimulation in the infraspinatus muscle for 2 months, 3 days/week, 20 min/day
Interventions/Control_2 The subjects don't perform any exercises.
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
40 years-old >=
Gender Male
Key inclusion criteria healthy adult men
Key exclusion criteria 1 Patients having any orthopedic or neurological disorders in either shoulder.

2 Athletes using upper limbs in the daily activity
Target sample size 52

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriaki Ichihashi
Organization Human Health Sciences, Graduate School of Medicine, Kyoto University
Division name Department of Development and Rehabilitation of Motor Function
Zip code
Address 606-8507 53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL 0757513935
Email ichihashi.noriaki.5z@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taishi Yamauchi
Organization Human Health Sciences, Graduate School of Medicine, Kyoto University
Division name Department of Development and Rehabilitation of Motor Function
Zip code
Address 606-8507 53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL 0757513935
Homepage URL
Email yamauchi.taishi.83z@st.kyoto-u.ac.jp

Sponsor
Institute Department of Development
and Rehabilitation of Motor Function,
Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 02 Month 06 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 Open public recruiting
Date of protocol fixation
2014 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 06 Day
Last modified on
2014 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015279

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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