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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Stroke | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 | ||||||
rehabmed@fujita-hu.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB | |||||||
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |