UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030468
Receipt number R000034790
Scientific Title Effect of magnetic stimulation for motor function disorder in patients with lower limb paralysis
Date of disclosure of the study information 2017/12/20
Last modified on 2017/12/19 16:46:15

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Basic information

Public title

Effect of magnetic stimulation for motor function disorder in patients with lower limb paralysis

Acronym

Effect of magnetic stimulation for lower limb paralysis patients

Scientific Title

Effect of magnetic stimulation for motor function disorder in patients with lower limb paralysis

Scientific Title:Acronym

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

1st name
Middle name
Last name Eiichi Saitoh

Organization

Fujita Health University

Division name

Department of Rehabilitation Medicine I, School of Medicine

Zip code


Address

1-98, Denngakugakubo, Kutsukake, Toyoake, Aichi, Japan

TEL

0562-93-2167

Email

rehabmed@fujita-hu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroki Tanikawa

Organization

Fujita Health University

Division name

Faculty of Rehabilitation, School of Health Sciences

Zip code


Address

1-98, Denngakugakubo, Kutsukake, Toyoake, Aichi, Japan

TEL

0562-93-9000

Homepage URL


Email

tanikawa@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



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

2017 Year 12 Month 20 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

Open public recruiting

Date of protocol fixation

2017 Year 12 Month 19 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034790


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name