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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031957
Receipt No. R000036495
Scientific Title Prevention of shoulder subluxation in stroke patients with magnetic stimulation: A randomized controlled trial
Date of disclosure of the study information 2018/03/29
Last modified on 2020/03/02

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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


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