UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037915 |
|---|---|
| Receipt number | R000042649 |
| Scientific Title | Effect of electrical muscle stimulation on motor unit behavior in healthy subjects: randomized control trial |
| Date of disclosure of the study information | 2019/09/04 |
| Last modified on | 2020/08/25 13:09:24 |
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Basic information
Public title
Effect of electrical muscle stimulation on motor unit behavior
Acronym
Effect of electrical muscle stimulation on motor unit behavior
Scientific Title
Effect of electrical muscle stimulation on motor unit behavior in healthy subjects: randomized control trial
Scientific Title:Acronym
Effect of electrical muscle stimulation on motor unit behavior in healthy subjects: randomized control trial
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study was to clarify the effect of EMS intervention on muscle activation pattern in healthy young adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
motor unit behavior
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Electrical muscle stimulation group
Electrical muscle stimulation
For bilateral lower limb
3 days / week for 1 month
Interventions/Control_2
Control group
not intervention
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Person who can participate in intervention 3 days / week for 1 month.
Key exclusion criteria
Orthopaedic disorders of lower limb
Neuromuscular disorders
Person who performs intense exercise (full marathon etc.) during the intervention period
Person who is about to start exercise newly
Alcohol hypersensitivity
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kimura |
Organization
Hiroshima University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
734-8551
Address
1-2-3 kasumi minami-ku, Hiroshima
TEL
082-257-5566
luna@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Nishikawa |
Organization
Hiroshima University Hospital
Division name
Division of Rehabilitation, Department of Clinical support and practice
Zip code
734-8551
Address
1-2-3 kasumi minami-ku, Hiroshima
TEL
082-257-5566
Homepage URL
yuichi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self finding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
N/A
Name of secondary funder(s)
N/A
IRB Contact (For public release)
Organization
Hiroshima University hospital IRB
Address
1-2-3 kasumi minami-ku, Hiroshima
Tel
082-257-5596
hugcp@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
| 2019 | Year | 09 | Month | 04 | 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
60
Results
The knee extension torque was significantly increased in the intervention group compared with the control group.
However, the muscle mass did not show a significant difference between pre and post intervention in each group.
The muscle activation patterns of 50% and 70% MVC task showed significant enhancement between baseline and four weeks in the intervention group,
but not in the control group.
Results date posted
| 2020 | Year | 08 | Month | 25 | Day |
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
| 2019 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 03 | Day |
Last modified on
| 2020 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042649
