UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of magnetic stimulation for motor function disorder in patients with lower limb paralysis
Title of the study (Brief title)	Effect of magnetic stimulation for lower limb paralysis patients
Region	Japan

Condition
Condition	Patients with lower limb paralysis
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effects of magnetic stimulation for spinal nerve.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Motion analysis using a 3D motion analysis system Just before the intervention, just after the intervention, once a week after the invention
Key secondary outcomes	Range of motion, muscle strength, muscle tone, pain

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Magnetic stimulation for spinal nerve. 20 minutes a day, 2-4 weeks.
Interventions/Control_2
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	Healthy adults over 20 years old: With informed consent, and without brain diseases, neuropathy, muscular diseases, or respiratory diseases. Patients with lower limb paralysis: Inpatients that their general condition is stable and with informed consent. A pregnant woman.
Key exclusion criteria	Healthy adults over 20 years old: With brain diseases, neuropathy, muscular diseases, respiratory diseases, or history of epilepsy. Patients with lower limb paralysis: General condition is not stable, history of epilepsy, using a cardiac pacemaker, having a magnetic substance in the body, or a pregnant woman.
Target sample size	100

Research contact person
Name of lead principal investigator	Eiichi Saitoh
Organization	Fujita Health University
Division name	Department of Rehabilitation Medicine I, School of Medicine
Address	1-98, Denngakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL	0562-93-2167
Email	rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person	Hiroki Tanikawa
Organization	Fujita Health University
Division name	Faculty of Rehabilitation, School of Health Sciences
Address	1-98, Denngakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL	0562-93-9000
Homepage URL
Email	tanikawa@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health 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)

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	2017 Year 12 Month 20 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 12 Month 19 Day
Anticipated trial start date	2017 Year 12 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 12 Month 19 Day
Last modified on	2017 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034790