UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of repetitive peripheral magnetic stimulation for lower extremity of stroke patients with hemiplegia
Title of the study (Brief title)	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	Keita Suzuki
Organization	Kawasaki University of Medical Welfare
Division name	Department of Rehabilitation
Address	288 Matsushima, Kurashiki, Okayama
TEL	086-462-1111
Email	suzuki@mw.kawasaki-m.ac.jp

Public contact
Name of contact person	Keita Suzuki
Organization	Kawasaki University of Medical Welfare
Division name	Department of Rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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