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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003039
Receipt No. R000003683
Scientific Title Effect of electrical stimulation in post-stroke patients with dysphagia
Date of disclosure of the study information 2010/01/14
Last modified on 2014/10/10

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Basic information
Public title Effect of electrical stimulation in post-stroke patients with dysphagia
Acronym Effect of electrical stimulation for dysphagia
Scientific Title Effect of electrical stimulation in post-stroke patients with dysphagia
Scientific Title:Acronym Effect of electrical stimulation for dysphagia
Region
Japan

Condition
Condition Patinets with dysphagia
Classification by specialty
Medicine in general Neurology Geriatrics
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of electrical stimulation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Videofluorography, Fujishima's grade, Motion analysis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 With electrical stimulation
Interventions/Control_2 Without electrical stimulation
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
30 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients with dysphagia
Key exclusion criteria Severe aphagia, dementia, loss of consciousness, children
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Matsumoto
Organization Kagoshima University
Division name Department of Rehabilitation and Physical Medicine
Zip code
Address 3930-7 Takachiho, Makizono-cho, Kirishima City
TEL 0995-78-2538
Email shushu@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuji Matsumoto
Organization Kagoshima University
Division name Department of Rehabilitation and Physical Medicine
Zip code
Address Kirishima City
TEL 0995-78-2538
Homepage URL
Email shushu@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University
Institute
Department

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
2010 Year 01 Month 14 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 Enrolling by invitation
Date of protocol fixation
2010 Year 01 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 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
2010 Year 01 Month 14 Day
Last modified on
2014 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003683

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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