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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004035
Receipt No. R000004855
Scientific Title Effect of electrical stimulation with outside trigger in hemiplegic lower limb of post-stroke patinets
Date of disclosure of the study information 2010/08/13
Last modified on 2011/08/12

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Basic information
Public title Effect of electrical stimulation with outside trigger in hemiplegic lower limb of post-stroke patinets
Acronym Effect of selective electrical stimulation
Scientific Title Effect of electrical stimulation with outside trigger in hemiplegic lower limb of post-stroke patinets
Scientific Title:Acronym Effect of selective electrical stimulation
Region
Japan

Condition
Condition Hemiplegic patinets with brain injury
Classification by specialty
Medicine in general Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

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

Assessment
Primary outcomes Active range of motion at ankle, modified Ashworth Scale (MAS), Fugl-Meyer Assessment of lower limb, Gait pattern scale, 10m gait measurement, Gait analyis (3D)
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
Interventions/Control_1 Group with electrical stimulation
Interventions/Control_2 Group 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 stroke whose onset are between one and six months
Key exclusion criteria severe higher brain dysfunction, dementia, loss of consciousness, children, patinets with pace-maker
Target sample size 50

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
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kagoshima University
Division name Department of Rehabilitation and Physical Medicine
Zip code
Address
TEL
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 08 Month 13 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 08 Month 13 Day
Date of IRB
Anticipated trial start date
2010 Year 08 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 08 Month 12 Day
Last modified on
2011 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004855

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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