UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056076 |
|---|---|
| Receipt number | R000064075 |
| Scientific Title | A pilot study of peripheral magnetic stimulation combined with physical therapy for motor function in early acute stroke survivors with sensory ataxic hemiparesis |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2024/11/06 16:25:37 |
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Basic information
Public title
repetitive peripheral magnetic stimulation for motor recovery with sensory ataxia post stroke
Acronym
rPMS for motor recovery and sensory ataxia
Scientific Title
A pilot study of peripheral magnetic stimulation combined with physical therapy for motor function in early acute stroke survivors with sensory ataxic hemiparesis
Scientific Title:Acronym
Effects of rPMS on motor and sensory recovery poststroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our aim was to explore the feasibility of repetitive peripheral magnetic stimulation (rPMS) for improving upper extremity (UE) function and proprioceptive sensory ataxic hemiparesis in early acute stroke survivors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl Meyer motor assessment estimation before and after intervention
Key secondary outcomes
Wolf Motor Function Test (WMFT) estimation before session and after
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group eight sessions, with delivery of rPMS (20 minutes) before 20 min occupational therapy (OT)
Interventions/Control_2
Control group eight sessions of 40 min of PT
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
medically stable condition
inpatients within 2 weeks of stroke onset
aged 40-90 years
intact skin on the affected UE
adequate mental state to participate
first-ever UE paresis
proprioceptive impairment
Key exclusion criteria
(1) history of damage from stroke, brain injury, or brain tumor; (2) metal implant in the head or within the stimulation area; (3) aphasia; (4) history of cardiac arrhythmia with hemodynamic instability; (5) comorbidity with neurodegenerative diseases and mental disorders; (6) uncontrolled seizures; (7) impaired consciousness; and (8) implanted stimulators (such as cardiac pacemakers or defibrillators).
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | shigeru |
| Middle name | |
| Last name | Obayashi |
Organization
Saitama medical center Saitama medical University
Division name
Department of rehabilitation medicine
Zip code
350-8550
Address
1981 Kamoda Kawagoe city, Saitama 350-8550, Japan
TEL
049-228-3529
ohbayash@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | shigeru |
| Middle name | |
| Last name | Obayashi |
Organization
Saitama medical University
Division name
Department of rehabilitation medicine
Zip code
350-8550
Address
1981 kamoda kawagoe 350-8550, Saitama, Japan
TEL
049-228-3529
Homepage URL
ohbayash@saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical University
Institute
Department
Personal name
Funding Source
Organization
saitama medical University
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
Saitama medical center Saitama medical University
Address
1981 Kamoda kawagoe 350-8550, Saitama, Japan
Tel
049-228-3529
ohbayash@saitama-med.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
埼玉医科大学総合医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2024 | Year | 11 | Month | 06 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064075
