UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031957 |
|---|---|
| Receipt number | 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 | 2023/04/20 00:15:03 |
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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
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
rehabmed@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University
Institute
Department
Personal name
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
| 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 16 | Day |
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
| 2023 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036495
