UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008330
Receipt number R000009805
Scientific Title The study of the effect of electrical muscle stimulation on the prevention of disuse muscle atrophy in patients with consciousness disturbance: Single center parallel randomised controlled, open label, trial.
Date of disclosure of the study information 2012/07/04
Last modified on 2012/07/03 17:08:16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The study of the effect of electrical muscle stimulation on the prevention of disuse muscle atrophy in patients with consciousness disturbance: Single center parallel randomised controlled, open label, trial.

Acronym

The study of the effect of electrical muscle stimulation on the prevention of disuse muscle atrophy

Scientific Title

The study of the effect of electrical muscle stimulation on the prevention of disuse muscle atrophy in patients with consciousness disturbance: Single center parallel randomised controlled, open label, trial.

Scientific Title:Acronym

The study of the effect of electrical muscle stimulation on the prevention of disuse muscle atrophy

Region

Japan


Condition

Condition

patients with consciousness disturbance

Classification by specialty

Emergency medicine Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We examined preventive effects of electrical muscle stimulation (EMS) against disuse atrophy of the lower limbs in patients with consciousness disturbance.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The changes in cross-sectional area of lower limb muscles with computed tomography

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is 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 (EMS) group: EMS was performed for 30 minutes simultaneously on the lower limbs daily from day 7 after admission.

Interventions/Control_2

Control group: no 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

16 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

Remained consciousness disturbance more than 24 hours after hospitalization
First-time stroke or TBI (traumatic brain injury)
Age between 16 to 75 years
Paralysis of one or both lower limbs
Ability to live independently before the acute brain insult

Key exclusion criteria

Muscle disease
TBI patients with other associated thoracic or abdominal injury

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tadahiko Shiozaki

Organization

Osaka University Graduate School of Medicine

Division name

Department of Traumatology and Acute Critical Medicine

Zip code


Address

2-15 Yamadaoka Suita, Osaka 565-0871, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Osaka University Graduate School of Medicine

Division name

Department of Traumatology and Acute Critical Medicine

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Grant-in-aid for scientific research from the Ministry of Education, Culture, Sports, Science, and Technology in Japan (no. 24390401)

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)

Grant from the Marine and Fire Insurance Association of Japan, Inc.


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

2012 Year 07 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


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

Completed

Date of protocol fixation

2005 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2005 Year 01 Month 01 Day

Last follow-up date

2010 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 07 Month 03 Day

Last modified on

2012 Year 07 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009805


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name