UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028687
Receipt number 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 2020/02/23 14:16:23

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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 Masahiko
Middle name
Last name Bundo

Organization

National Center for Geriatrics and Gerontology

Division name

Department of Neurosurgery

Zip code

474-8511

Address

7-430 Morioka-cho Obu Aichi

TEL

0562462311

Email

ibundou@ncgg.go.jp


Public contact

Name of contact person

1st name Masahiko
Middle name
Last name Bundo

Organization

National Center for Geriatrics and Gerontology

Division name

Department of Neurosurgery

Zip code

474-8511

Address

7-430 Morioka-cho Obu Aichi

TEL

0562462311

Homepage URL


Email

ibundou@ncgg.go.jp


Sponsor or person

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name



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

National center for geriatrics and gerontology

Address

7-430 Morioka-cho Obu Aichi

Tel

0562-46-2311

Email

yaday@ncgg.go.jp


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

2020 Year 02 Month 23 Day



Link to view the page

Value
https://center6.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