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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032101
Receipt No. R000036625
Scientific Title Repetitive peripheral magnetic stimulation for ambulation after stroke
Date of disclosure of the study information 2018/04/12
Last modified on 2019/02/16

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Basic information
Public title Repetitive peripheral magnetic stimulation for ambulation after stroke
Acronym rPMS for ambulation afte stroke
Scientific Title Repetitive peripheral magnetic stimulation for ambulation after stroke
Scientific Title:Acronym rPMS for ambulation afte stroke
Region
Japan

Condition
Condition stroke (cerebrovascular disease)
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the efficacy of rPMS for ambulation after stroke.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 10-meter walk test before and after the treatment.
Key secondary outcomes Functional ambulation category(FAC), 6-minute walk test, timed up and go (TUG) test, range of Motion (ROM), modified Ashworth scale and 30-second Chair stand test.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Repetitive peripheral magnetic stimulation wi be administrated using parabolic coil (MMC 140). The intensity of stimulation will be set as 10% above the level that evoked a leg movement. The frequency will be 20 to 25 Hz. The duration of stimulation will be 1 to 3 second after rest time. 10 to 20 times of stimulation will be administrated for 14 to 21 days.
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
18 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Stroke patients with hemiparesis
2) Functional Ambulation Category (FAC) 1 - 4
3) Patients who do not have cognitive impairment and be able to understand the study protocol.
Key exclusion criteria 1) Metal implants in the head or within the stimulation area
2) Medical implanted devices (cardiac pacemaker, etc)
3) Pregnancy
4) History of recent epilepsy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoji Kinoshita
Organization Aomori Shintoshi Hospital
Division name Department of rehabilitation medicine
Zip code
Address 105-18, Ishie-takama, Aomori, Aomori
TEL 017-757-8750
Email s-kinoshita@yushinkai.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoji Kinoshita
Organization Aomori Shintoshi Hospital
Division name Department of rehabilitation medicine
Zip code
Address 105-18, Ishie-takama, Aomori, Aomori
TEL 017-757-8750
Homepage URL
Email s-kinoshita@yushinkai.jp

Sponsor
Institute Aomori Shintoshi Hospital
Institute
Department

Funding Source
Organization Aomori Shintoshi Hospital
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
2018 Year 04 Month 12 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
2018 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 10 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 04 Day
Last modified on
2019 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036625

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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