Tokyo, Sept. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059088) titled 'The effect of belt-type electrical stimulation on muscle activity' on Sept. 15.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Kanazawa University
Condition:
Condition - healthy
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Electrical stimulation
Interventions/Control_2 - voluntary contraction
Eligibility:
Age-lower limit - 18
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 Size - 20
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067590
Disclaimer: Curated by HT Syndication.
