UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047323 |
|---|---|
| Receipt number | R000053976 |
| Scientific Title | Effects of repetitive peripheral magnetic sitmulation on motor recovery of paretic upper extremity after stroke |
| Date of disclosure of the study information | 2022/03/30 |
| Last modified on | 2022/03/30 13:46:52 |
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Basic information
Public title
Neurorehabilitation of paretic upper extremity after stroke
using rPMS
Acronym
Neurorehabilitation of stroke using rPMS
Scientific Title
Effects of repetitive peripheral magnetic
sitmulation on motor recovery of paretic upper extremity
after stroke
Scientific Title:Acronym
Effects of rPMS on UE function after stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the effects of rPMS on paretic UE function after stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fugl-Meyer assessment of upper extremities (FMA)
was estimated at baseline, 1 week after , and 2 week after intervention.
Key secondary outcomes
Wolf motor function test
Box and Block test
Manual function test (MFT)
SIAS(stroke impairment assessment set)
grip power
Each measure was estimated at baseline, 1 week after , and 2 week after intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
rPMS preconditioning prior to standard care of 40 minutes for 10 days
Interventions/Control_2
standard care of 40 minutes for 10 days
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) medically stable; (2) hospitalized adults within two weeks of stroke; (3) age 20 to 89 years; (4) intact skin on the hemiparetic arm; (5) adequate cognition to participate; (6) first-ever, severe UE paresis (stroke impairment assessment set (SIAS): knee-mouth test ranging 1 to 3; finger function test 1a to 3).
Key exclusion criteria
(1) past history of stroke or brain injury or brain tumor; (2) metal implant in the head or within the stimulation area; (3) dysphasia; (4) history of cardiac arrhythmia with hemodynamic instability; (5) comorbidity with neurodegenerative diseases and mental disorders; (6) uncontrolled seizure disorder; (7) disturbed consciousness; (8) implanted stimulator (such as cardiac pacemaker); (9) pregnancy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Obayashi |
Organization
Dokkyo medical University, Saitama medical center
Division name
Department of rehabilitation medicine
Zip code
343-8555
Address
2-1-50 minami-Koshigaya Koshigaya city, Saitama, JAPAN
TEL
048-965-1111
ohbayash@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Obayashi |
Organization
Dokkyo medical University, Saitama medical center
Division name
Department of rehabilitation medicine
Zip code
343-8555
Address
2-1-50 minami-Koshigaya Koshigaya city, Saitama, JAPAN
TEL
048-965-1111
Homepage URL
ohbayash@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo medical University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research, Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo medical University, Saitama medical center, IRB section
Address
2-1-50 minami-Koshigaya Koshigaya city, Saitama, JAPAN
Tel
048-965-0658
k-shien@dokkyomed.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
| 2022 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3233/NRE-203085
Number of participants that the trial has enrolled
19
Results
The present study suggested the beneficial effect of rPMS for severe UE paresis during early acute phase of stroke.
This is the first report describing beneficial effects of rPMS on severe UE dysfunction during early acute phase of stroke when applying rPMS to the whole UE. These findings would contribute to the justification for specific treatment parameters to maximize severe UE recovery after stroke.
Results date posted
| 2022 | Year | 03 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 03 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 30 | Day |
Last modified on
| 2022 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053976
