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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018750
Receipt No. R000021679
Scientific Title Effect of repetitive peripheral magnetic stimulation for lower extremity of stroke patients with hemiplegia
Date of disclosure of the study information 2015/08/21
Last modified on 2017/12/12

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Basic information
Public title Effect of repetitive peripheral magnetic stimulation for lower extremity of stroke patients with hemiplegia
Acronym Repetitive peripheral magnetic stimulation for patients with hemiplegia
Scientific Title Effect of repetitive peripheral magnetic stimulation for lower extremity of stroke patients with hemiplegia
Scientific Title:Acronym Repetitive peripheral magnetic stimulation for patients with hemiplegia
Region
Japan

Condition
Condition stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of the therapeutic effects of repetitive peripheral magnetic stimulation for lower limb of stroke patients with hemiplegia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Knee extension strength

Evaluation time: At the time of a physical therapy start, 1 week later, 2 week later, 1 month later, 2 month later
Key secondary outcomes Stroke Impairment Assessment Set
10 meter walking speed
Functional Independence Measure
Quadriceps muscle thickness
Acceleration during walking
Berg Balance Scale
Timed Up and Go test
Biochemical blood test
Number of days until gait reacquisition
Hospitalization

Base
Study type Interventional

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 Maneuver
Interventions/Control_1 Repetitive peripheral magnetic stimulation + Standard physical therapy
Repetitive peripheral magnetic stimulation: While patients are participating in this study, they receive repetitive peripheral magnetic stimulation on the day of performing physical therapy. Repetitive peripheral magnetic stimulation is performed to quadriceps femoris at 30 Hz for 10 minutes.
Interventions/Control_2 Standard physical therapy
Standard physical therapy is performed at standard schedule of our hospital.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cerebral hemisphere damage
People that had independent walking
modified Rankin Scale is between 0 to 2 before the onset
First cerebrovascular accident
Key exclusion criteria Severe dementia
Patients that correspond to contraindications matters of the guidelines for the use of repetitive transcranial magnetic stimulation.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keita Suzuki
Organization Kawasaki University of Medical Welfare
Division name Department of Rehabilitation
Zip code
Address 288 Matsushima, Kurashiki, Okayama
TEL 086-462-1111
Email suzuki@mw.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keita Suzuki
Organization Kawasaki University of Medical Welfare
Division name Department of Rehabilitation
Zip code
Address 288 Matsushima, Kurashiki, Okayama
TEL 086-462-1111
Homepage URL
Email suzuki@mw.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki University of Medical Welfare
Organization
Division
Category of Funding Organization Other
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 川崎医科大学附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 21 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
2015 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 21 Day
Last modified on
2017 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021679

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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