UMIN-CTR Clinical Trial

Basic information
Public title	Neurorehabilitation of paretic upper extremity after stroke using rPMS
Acronym	Neurorehabilitation of stroke using rPMS
Scientific Title	Effects of repetitive peripheral magnetic sitmulation on motor recovery of paretic upper extremity after stroke
Scientific Title:Acronym	Effects of rPMS on UE function after stroke
Region	Japan

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

Objectives
Narrative objectives1	to investigate the effects of rPMS on paretic UE function after stroke
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Fugl-Meyer assessment of upper extremities (FMA) was estimated at baseline, 1 week after , and 2 week after intervention.
Key secondary outcomes	Wolf motor function test Box and Block test Manual function test (MFT) SIAS(stroke impairment assessment set) grip power Each measure was estimated at baseline, 1 week after , and 2 week after intervention.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	rPMS preconditioning prior to standard care of 40 minutes for 10 days
Interventions/Control_2	standard care of 40 minutes for 10 days
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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	(1) medically stable; (2) hospitalized adults within two weeks of stroke; (3) age 20 to 89 years; (4) intact skin on the hemiparetic arm; (5) adequate cognition to participate; (6) first-ever, severe UE paresis (stroke impairment assessment set (SIAS): knee-mouth test ranging 1 to 3; finger function test 1a to 3).
Key exclusion criteria	(1) past history of stroke or brain injury or brain tumor; (2) metal implant in the head or within the stimulation area; (3) dysphasia; (4) history of cardiac arrhythmia with hemodynamic instability; (5) comorbidity with neurodegenerative diseases and mental disorders; (6) uncontrolled seizure disorder; (7) disturbed consciousness; (8) implanted stimulator (such as cardiac pacemaker); (9) pregnancy
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shigeru Middle name Last name Obayashi
Organization	Dokkyo medical University, Saitama medical center
Division name	Department of rehabilitation medicine
Zip code	343-8555
Address	2-1-50 minami-Koshigaya Koshigaya city, Saitama, JAPAN
TEL	048-965-1111
Email	ohbayash@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Shigeru Middle name Last name Obayashi
Organization	Dokkyo medical University, Saitama medical center
Division name	Department of rehabilitation medicine
Zip code	343-8555
Address	2-1-50 minami-Koshigaya Koshigaya city, Saitama, JAPAN
TEL	048-965-1111
Homepage URL
Email	ohbayash@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo medical University
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research, Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Dokkyo medical University, Saitama medical center, IRB section
Address	2-1-50 minami-Koshigaya Koshigaya city, Saitama, JAPAN
Tel	048-965-0658
Email	k-shien@dokkyomed.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	2022 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.3233/NRE-203085
Number of participants that the trial has enrolled	19
Results	The present study suggested the beneficial effect of rPMS for severe UE paresis during early acute phase of stroke. This is the first report describing beneficial effects of rPMS on severe UE dysfunction during early acute phase of stroke when applying rPMS to the whole UE. These findings would contribute to the justification for specific treatment parameters to maximize severe UE recovery after stroke.
Results date posted	2022 Year 03 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 03 Month 01 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2019 Year 02 Month 01 Day
Date of IRB	2019 Year 02 Month 01 Day
Anticipated trial start date	2019 Year 02 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 03 Month 30 Day
Last modified on	2022 Year 03 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053976