UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059088 |
|---|---|
| Receipt number | R000067590 |
| Scientific Title | The effect of belt-type electrical stimulation on muscle activity |
| Date of disclosure of the study information | 2025/09/15 |
| Last modified on | 2025/09/15 00:13:41 |
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Basic information
Public title
The effect of belt-type electrical stimulation on muscle activity
Acronym
The effect of belt-type electrical stimulation on muscle activity
Scientific Title
The effect of belt-type electrical stimulation on muscle activity
Scientific Title:Acronym
The effect of belt-type electrical stimulation on muscle activity
Region
| Japan |
Condition
Condition
healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Electrical stimulators are devices that electrically excite peripheral nerves and induce muscle contraction. They are used in a wide range of rehabilitation applications, including preventing muscle atrophy due to immobility and strengthening athletes' muscles. In recent years, belt-type electrical stimulators (B-SES) have been developed, enabling electrical stimulation over a wide range of areas. However, the effects of B-SES on deep muscle contraction remain unclear. Therefore, the purpose of this study was to determine whether deep muscle activity occurs during B-SES by examining changes in muscle thickness using ultrasound imaging. If deep muscle contraction can be confirmed through B-SES, long-term use may improve deep muscle function, potentially enabling application as a rehabilitation method contributing to spinal stabilization. This is believed to have great social and clinical value.
This study was not intended to evaluate the efficacy or safety of belt-type electrical stimulators.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle Thickness
Key secondary outcomes
Muscle intensity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Electrical stimulation
Interventions/Control_2
voluntary contraction
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals with no history of central or peripheral nervous system disorders
Individuals who can provide written informed consent to participate in this study
Individuals aged 18 years or older at the time of consent
Key exclusion criteria
Individuals with an implanted pacemaker or other biostimulator
Pregnant individuals or individuals with a possibility of pregnancy
Individuals with a history of malignant tumors
Individuals with wounds or sensory impairments at the electrode attachment site
Individuals deemed inappropriate for participation by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kubota |
| Middle name | |
| Last name | Masafumi |
Organization
Kanazawa University
Division name
Department of Physical Therapy, Faculty of Health Sciences, Institute of Medical, Pharmaceutical and Health Sciences,
Zip code
920-0942
Address
Kodatsuno 5-11-80, Kanazawa
TEL
0762652617
mkubota@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kubota |
| Middle name | |
| Last name | Masafumi |
Organization
Kanazawa University
Division name
Department of Physical Therapy, Faculty of Health Sciences, Institute of Medical, Pharmaceutical and
Zip code
920-0942
Address
Kodatsuno 5-11-80, Kanazawa
TEL
0762652617
Homepage URL
mkubota@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa 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
Medical Ethics Committee of Kanazawa University
Address
Takaramachi13-1, Kanazawa
Tel
076-265-2110
rinri@adm.kanazawa-u.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
| 2025 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 09 | Month | 15 | Day |
Last modified on
| 2025 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067590
