UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018750 |
|---|---|
| Receipt number | R000021679 |
| Scientific Title | Effect of repetitive peripheral magnetic stimulation for lower extremity of stroke patients with hemiplegia |
| Date of disclosure of the study information | 2015/08/21 |
| Last modified on | 2017/12/12 18:39:20 |
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Basic information
Public title
Effect of repetitive peripheral magnetic stimulation for lower extremity of stroke patients with hemiplegia
Acronym
Repetitive peripheral magnetic stimulation for patients with hemiplegia
Scientific Title
Effect of repetitive peripheral magnetic stimulation for lower extremity of stroke patients with hemiplegia
Scientific Title:Acronym
Repetitive peripheral magnetic stimulation for patients with hemiplegia
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the therapeutic effects of repetitive peripheral magnetic stimulation for lower limb of stroke patients with hemiplegia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee extension strength
Evaluation time: At the time of a physical therapy start, 1 week later, 2 week later, 1 month later, 2 month later
Key secondary outcomes
Stroke Impairment Assessment Set
10 meter walking speed
Functional Independence Measure
Quadriceps muscle thickness
Acceleration during walking
Berg Balance Scale
Timed Up and Go test
Biochemical blood test
Number of days until gait reacquisition
Hospitalization
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Repetitive peripheral magnetic stimulation + Standard physical therapy
Repetitive peripheral magnetic stimulation: While patients are participating in this study, they receive repetitive peripheral magnetic stimulation on the day of performing physical therapy. Repetitive peripheral magnetic stimulation is performed to quadriceps femoris at 30 Hz for 10 minutes.
Interventions/Control_2
Standard physical therapy
Standard physical therapy is performed at standard schedule of our hospital.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cerebral hemisphere damage
People that had independent walking
modified Rankin Scale is between 0 to 2 before the onset
First cerebrovascular accident
Key exclusion criteria
Severe dementia
Patients that correspond to contraindications matters of the guidelines for the use of repetitive transcranial magnetic stimulation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keita Suzuki |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Rehabilitation
Zip code
Address
288 Matsushima, Kurashiki, Okayama
TEL
086-462-1111
suzuki@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keita Suzuki |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Rehabilitation
Zip code
Address
288 Matsushima, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
suzuki@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki University of Medical Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
川崎医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 21 | 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
| 2015 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 21 | Day |
Last modified on
| 2017 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021679
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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