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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025212
Receipt No. R000029000
Scientific Title The effect of repetitive facilitative exercise synchronized with transcranial magnetic stimulation on hemiplegic upper limb
Date of disclosure of the study information 2016/12/28
Last modified on 2017/04/03

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Basic information
Public title The effect of repetitive facilitative exercise synchronized with transcranial magnetic stimulation on hemiplegic upper limb
Acronym RFE synchronized with TMS
Scientific Title The effect of repetitive facilitative exercise synchronized with transcranial magnetic stimulation on hemiplegic upper limb
Scientific Title:Acronym RFE synchronized with TMS
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 repetitive facilitative exercise synchronized with transcranial magnetic stimulation on hemiplegic upper limb
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fugl-Meyer Assessment (upper limb)
Key secondary outcomes Action Research Arm Test
Modified Ashworth Scale
resting motor threshold
amplitude of motor evoked potential
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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 repetitive facilitative exercise synchronized with transcranial magnetic stimulation
(50-200 stimulation/day, 5 days/week, 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
15 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) admitted patients in Kirishima Rehabilitation Center in Kagoshima University
2) more than Brunnstrom stage 2 in hemiplegic upper limb
Key exclusion criteria 1) clinically unstable medical disorders
2) pain and contracture of the upper limb
3) severe aphasia that made it impossible to follow the verbal instructions of the therapist
4) intracranial metallic implants
5) seizures
Target sample size 20

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

Sponsor
Institute Department of Rehabilitation and PhysicalMedicine, Guraduate School of Medical and Dental Sciences, Kagoshima University
Institute
Department

Funding Source
Organization Department of Rehabilitation and PhysicalMedicine, Guraduate School of Medical and Dental Sciences, Kagoshima University
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
2016 Year 12 Month 28 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 Enrolling by invitation
Date of protocol fixation
2016 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 02 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
2016 Year 12 Month 10 Day
Last modified on
2017 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029000

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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