UMIN-CTR Clinical Trial

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 Seiji Middle name Last name Etoh
Organization	Guraduate School of Medical and Dental Sciences, Kagoshima University
Division name	Department of Rehabilitation and PhysicalMedicine
Zip code	890-8520
Address	Sakuragaoka 8-35-1, Kagoshima-City, Kagoshima, Japan
TEL	0992755339
Email	etohs@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	1st name Seiji Middle name Last name Etoh
Organization	Guraduate School of Medical and Dental Sciences, Kagoshima University
Division name	Department of Rehabilitation and PhysicalMedicine
Zip code	890-8520
Address	Sakuragaoka 8-35-1, Kagoshima-City, Kagoshima, Japan
TEL	0992755339
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	Department of Rehabilitation and PhysicalMedicine, Guraduate School of Medical and Dental Sciences, Kagoshima University
Address	Sakuragaoka 8-35-1, Kagoshima-City, Kagoshima, Japan
Tel	0992755339
Email	etohs@m2.kufm.kagoshima-u.ac.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	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	2016 Year 08 Month 01 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2024 Year 02 Month 01 Day
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	2021 Year 06 Month 14 Day

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