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 |
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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
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
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
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
