UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013096 |
|---|---|
| Receipt number | 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 19:20:45 |
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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
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
yamauchi.taishi.83z@st.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Development
and Rehabilitation of Motor Function,
Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015279
