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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name