UMIN-CTR Clinical Trial

Basic information
Public title	Prevention of shoulder subluxation in stroke patients with magnetic stimulation: A randomized controlled trial
Acronym	A randomized controlled trial for prevention of shoulder subluxation with magnetic stimulation
Scientific Title	Prevention of shoulder subluxation in stroke patients with magnetic stimulation: A randomized controlled trial
Scientific Title:Acronym	A randomized controlled trial for prevention of shoulder subluxation with magnetic stimulation
Region	Japan

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

Objectives
Narrative objectives1	To clarify the effect of prevention for shoulder subluxation in stroke patients with magnetic stimulation to shoulder muscles
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in humeral head position by X-ray examination after 6-week intervention
Key secondary outcomes	Changes in motor function, joint range of motion, muscle strength, and pain

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Six weeks magnetic stimulation in addition to usual training: 20 minutes stimulation per day, 5 days per week plus physical therapy and occupational therapy
Interventions/Control_2	Six weeks conventional training: usual physical therapy and occupational therapy
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with hemiplegia after stroke with stable general condition, and aged 20 or older who gave informed consent
Key exclusion criteria	Patients with unstable general condition, history of epilepsy, cardiac pacemaker, difficulty in sitting position over 40 minutes, had magnetic materials near the stimulation site, inpatients who are expected to discharge within 6 weeks and pregnant women. Patients whose distance between acromion and humeral head are more than 1/2 finger-breadth are also excluded.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Eiichi Middle name Last name Saitoh
Organization	Fujita Health University
Division name	Department of Rehabilitation Medicine I, School of Medicine
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
TEL	0562-93-2167
Email	rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Kenta Middle name Last name Fujimura
Organization	Fujita Health University
Division name	Faculty of Rehabilitation, School of Health Sciences
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
TEL	0562-93-9000
Homepage URL
Email	rehabmed@fujita-hu.ac.jp

Sponsor
Institute	Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fujita Health University
Address	1-98 Dengakugakubo, Kutsukake, Toyoake
Tel	0562-93-9000
Email	rehabmed@fujita-hu.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	2018 Year 03 Month 29 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	2018 Year 03 Month 29 Day
Date of IRB
Anticipated trial start date	2018 Year 04 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	2018 Year 03 Month 29 Day
Last modified on	2020 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036495

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.