UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060662 |
|---|---|
| Receipt number | R000068924 |
| Scientific Title | Verification of the effectiveness of combined therapy of exercise therapy and repetitive peripheral magnetic stimulation (rPMS) for improving lower limb function and movement in convalescent stroke patients; randomized crossover trial |
| Date of disclosure of the study information | 2026/02/15 |
| Last modified on | 2026/02/12 21:57:16 |
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Basic information
Public title
Verification of the effectiveness of combined therapy of exercise therapy and repetitive peripheral magnetic stimulation (rPMS) for improving lower limb function and movement in convalescent stroke patients; randomized crossover trial
Acronym
stroke
rPMS
Scientific Title
Verification of the effectiveness of combined therapy of exercise therapy and repetitive peripheral magnetic stimulation (rPMS) for improving lower limb function and movement in convalescent stroke patients; randomized crossover trial
Scientific Title:Acronym
stroke
rPMS
Region
| Japan |
Condition
Condition
Patients aged 40 or older to younger than 65
Patients admitted to our hospital's rehabilitation ward for rehabilitation treatment within 60 days of stroke onset
Patients who have had a first stroke and the type of stroke is unilateral cerebral infarction or cerebral hemorrhage
Patients with mild to moderate lower limb motor paralysis (Brunnstrom stage 3/4/5)
Patients with a degree of gait disorder with a Functional Ambulation Categories (FAC) score of 3/4
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of combined therapy of exercise therapy and repetitive peripheral magnetic stimulation (rPMS) on motor paralysis of the lower limbs of stroke patients with hemiplegia admitted to a convalescent rehabilitation ward.
With the medical environment demanding efficiency, explore the possibility of providing more effective exercise therapy and responding to early expansion of activities of daily living (ADL).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Manual muscle strength testing using a handheld dynamometer (HHD)
Key secondary outcomes
Functional Independence Measure(FIM)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Conventional rehabilitation and rPMS combination program
Interventions/Control_2
Conventional rehabilitation
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 40 or older to younger than 65
Patients admitted to our hospital's rehabilitation ward for rehabilitation treatment within 60 days of stroke onset
Patients who have had a first stroke and the type of stroke is unilateral cerebral infarction or cerebral hemorrhage
Patients with mild to moderate lower limb motor paralysis (Brunnstrom stage 3 to 5)
Patients with a degree of gait disorder with a Functional Ambulation Categories (FAC) score of 3 to 4
Key exclusion criteria
Patients with metal implants or implant devices (e.g. cardiac pacemaker) within the stimulation site
Pregnant patients
Patients with or history of epilepsy
Patients whose general conditions such as blood pressure, pulse rate, and blood sugar levels are unstable due to dyspnea on exertion, heart failure, arrhythmia, myocardial infarction, etc., and who are judged to have difficulty in functional training.
Patients with a history of neurological diseases or orthopedic diseases that affect trunk and lower extremity function *Patients with comorbid diseases such as degenerative diseases, scoliosis, osteoporosis, etc. whose symptoms are judged to be aggravated by functional training
Patients with subarachnoid hemorrhage, severe liver disorder, renal disorder, or cardiovascular disease
Patients with higher brain dysfunction such as severe sensory impairment, ataxia, or aphasia
Patients who do not have the capacity to consent themselves as research subjects
Patients whose attending physician has determined that they are unable to participate in this study, taking into account their general condition.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | kenji |
| Middle name | |
| Last name | yoshida |
Organization
Hakujuji Rehabilitation Hospital, Hakujuji Social Medical Corporation Foundation
Division name
rehabilitation department
Zip code
8198611
Address
3-3-9 Ishimaru, Nishi-ku, Fukuoka City, Fukuoka Prefecture
TEL
092-891-2611
pt.yoshida.hakujyuji@gmail.com
Public contact
Name of contact person
| 1st name | kenji |
| Middle name | |
| Last name | yoshida |
Organization
3-3-9 Ishimaru, Nishi-ku, Fukuoka City, Fukuoka Prefecture
Division name
rehabilitation department
Zip code
092-891-2611
Address
3-3-9 Ishimaru, Nishi-ku, Fukuoka City, Fukuoka Prefecture
TEL
092-891-2611
Homepage URL
pt.yoshida.hakujyuji@gmail.com
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakujuji Rehabilitation Hospital, Hakujuji Social Medical Corporation Foundation
Address
3-3-9 Ishimaru, Nishi-ku, Fukuoka City, Fukuoka Prefecture
Tel
092-891-2611
pt.yoshida.hakujyuji@gmail.com
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
| 2026 | Year | 02 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068924
