UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017993
Receipt number R000020849
Scientific Title Study of preventive effect of muscle atrophy, muscle weakness due to muscle electrical stimulation to the acute stroke patients
Date of disclosure of the study information 2015/07/01
Last modified on 2015/06/20 21:46:02

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Basic information

Public title

Study of preventive effect of muscle atrophy, muscle weakness due to muscle electrical stimulation to the acute stroke patients

Acronym

Muscle electrical stimulation to the acute stroke

Scientific Title

Study of preventive effect of muscle atrophy, muscle weakness due to muscle electrical stimulation to the acute stroke patients

Scientific Title:Acronym

Muscle electrical stimulation to the acute stroke

Region

Japan


Condition

Condition

acute stroke

Classification by specialty

Medicine in general Neurology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Use of 20 minutes per day to consider whether to improve the metabolism improvement and cognitive decline not only to improve the ADL of acute stroke patients by using a low-frequency muscle electrical stimulation device.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in the Barthel Index of up to 6 months

Key secondary outcomes



Base

Study type


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Rehabilitation and Low-frequency muscle stimulation

Interventions/Control_2

Rehabilitation

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Acute cerebral infarction patients with NIH stroke scale 2-10 points, after a week from onset
2.Age 40 years of age or older, and the upper limit is not provided
It is possible to rehabilitation hospital
3.patient of modified Rankin Scale (mRS) < 3
4.Informed consent of participation research has been obtained in writing from the patient or the family

Key exclusion criteria

1.Patients of mRS > 2 before the onset
2.Patients of Minimental test < 17
3.Study director or sharing doctors are judged unsuitable for the practice of the present test

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Arata Abe

Organization

Nippon Medical School

Division name

Neurology

Zip code


Address

Sendagi 1-1-5, Bunkyo-ku, Tokyo

TEL

03-6902-2210

Email

abe@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Arata Abe

Organization

Nippon Medical School

Division name

Neurology

Zip code


Address

Sendagi 1-1-5, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Homepage URL


Email

abe@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School, Department of Neurology

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


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

2015 Year 07 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


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

Preinitiation

Date of protocol fixation

2015 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 05 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

2015 Year 06 Month 20 Day

Last modified on

2015 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020849


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name