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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025795
Receipt No. R000029666
Scientific Title Effect of Repetitive facilitative exercise synchronized with transcranial magnetic stimulation on hemiplegia of upper limb in stroke patients
Date of disclosure of the study information 2017/01/26
Last modified on 2017/01/22

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Basic information
Public title Effect of Repetitive facilitative exercise synchronized with transcranial magnetic stimulation on hemiplegia of upper limb in stroke patients
Acronym TMS synchronized with RFE
Scientific Title Effect of Repetitive facilitative exercise synchronized with transcranial magnetic stimulation on hemiplegia of upper limb in stroke patients
Scientific Title:Acronym TMS synchronized with RFE
Region
Japan

Condition
Condition stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of the repetitive facilitative exercise synchronized with transcranial magnetic stimulation on hemiplegia of upper limb in stroke patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fugl-Meyer Assessment
Action Research Arm Test
Modified Ashworth Scale
Key secondary outcomes Box and Block test
Nine hole peg test

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
Maneuver
Interventions/Control_1 Patients receive the repetitive facilitative exercise synchronized with transcranial magnetic stimulation is applied for 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
18 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients in Kirishima Rehabilitation Center of Kagoshima University Hospital,
mild-to-moderate motor upper-limb deficits (Brunnstrom proximal upper-limb is more than stage 2)
Key exclusion criteria clinically unstable medical disorders,
pain and contracture of the upper limb,
severe aphasia that made it impossible to follow the verbal instructions of the therapist,
intracranial metallic implants,
seizures.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiji Etoh
Organization Graduate School of Medical and Dental Sciences
Division name Department of Rehabilitation and Physical Medicine
Zip code
Address Takachiho 3930-7, Makizono-Cho, Kirishima-City, Kagoshima, Japan
TEL 0995-78-2538
Email etohs@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiji Etoh
Organization Graduate School of Medical and Dental Sciences
Division name Department of Rehabilitation and Physical Medicine
Zip code
Address Takachiho 3930-7, Makizono-Cho, Kirishima-City, Kagoshima, Japan
TEL 0995-78-2538
Homepage URL
Email etohs@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization Other
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 01 Month 26 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 Terminated
Date of protocol fixation
2016 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 26 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 01 Month 22 Day
Last modified on
2017 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029666

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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