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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028687
Receipt No. R000032839
Scientific Title Exploratory randomized control study for the efficacy of repetitive transcranial magnetic stimulation and robotic rehabilitation on aged post stroke patients
Date of disclosure of the study information 2017/10/01
Last modified on 2017/08/16

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Basic information
Public title Exploratory randomized control study for the efficacy of repetitive transcranial magnetic stimulation and robotic rehabilitation on aged post stroke patients
Acronym Study for the Efficacy of rTMS and Robotic rehabilitation on Aged post stroke patients (SERRA)
Scientific Title Exploratory randomized control study for the efficacy of repetitive transcranial magnetic stimulation and robotic rehabilitation on aged post stroke patients
Scientific Title:Acronym Study for the Efficacy of rTMS and Robotic rehabilitation on Aged post stroke patients (SERRA)
Region
Japan

Condition
Condition Cerebral infarction or hemorrhage
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the efficacy of repetitive transcranial magnetic stimulation combined with robotic rehabilitation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of Functional Skills Measure Paralysis(FSMAP) score, as of one month after start of therapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 repetitive transcranial magnetic stimulation plus robotic rehabilitation (twice a day, 2 weeks)
Interventions/Control_2 sham magnetic stimulation plus robotic rehabilitation (twice a day, 2 weeks)
Interventions/Control_3 sham magnetic stimulation plus conventional rehabilitation(twice a day, 2 weeks)
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
75 years-old <=
Age-upper limit
89 years-old >=
Gender Male and Female
Key inclusion criteria Brunnstrom stage > 2
More than 3 months passed from disease onset
single lesion
Asworth scale <5
MMSE > 23
Key exclusion criteria Evidence of epilepsy
Contraindications for transcranial magnetic stimulation (aneurysmal clip, pace maker, et al.)
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Bundo
Organization National Center for Geriatrics and Gerontology
Division name Department of Neurosurgery
Zip code
Address 7-430 Morioka-cho Obu Aichi
TEL 0562462311
Email ibundou@ncgg.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Bundo
Organization National Center for Geriatrics and Gerontology
Division name Department of Neurosurgery
Zip code
Address 7-430 Morioka-cho Obu Aichi
TEL 0562462311
Homepage URL
Email ibundou@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization Japanese Governmental office
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 10 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 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 08 Month 16 Day
Last modified on
2017 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032839

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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