UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057180 |
|---|---|
| Receipt number | R000065361 |
| Scientific Title | Investigating the Effects of Lower Extremity Belt Electrical Stimulation on Muscle Temperature |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2025/02/28 18:35:14 |
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Basic information
Public title
Investigating the Effects of Lower Extremity Belt Electrical Stimulation on Muscle Temperature
Acronym
Investigating the Effects of Lower Extremity Belt Electrical Stimulation on Muscle Temperature
Scientific Title
Investigating the Effects of Lower Extremity Belt Electrical Stimulation on Muscle Temperature
Scientific Title:Acronym
Investigating the Effects of Lower Extremity Belt Electrical Stimulation on Muscle Temperature
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of belt-type lower limb electrical stimulation on muscle temperature.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Muscle temperature (before the initiation of electrical stimulation and every minute for 10 minutes after initiation)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
belt electrode-skeletal muscle electrical stimulation (low-frequency)
Interventions/Control_2
belt electrode-skeletal muscle electrical stimulation (low-frequency)
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
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18 to 25 years.
Key exclusion criteria
(1) currently receiving medical treatment for an illness or injury
(2) history of stroke or cardiovascular disease or psychiatric disorder.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Katsuyoshi |
| Middle name | |
| Last name | Tanaka |
Organization
Bukkyo University
Division name
Department of Physical Therapy, School of Health Science
Zip code
604-8415
Address
7 Nishinokyohigashitoganoocho, Nakagyo-ku, Kyoto
TEL
075-491-2141
tanaka-k@bukkyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Katsuyoshi |
| Middle name | |
| Last name | Tanaka |
Organization
Bukkyo University
Division name
Department of Physical Therapy, School of Health Science
Zip code
604-8415
Address
7 Nishinokyohigashitoganoocho, Nakagyo-ku, Kyoto
TEL
075-491-2141
Homepage URL
tanaka-k@bukkyo-u.ac.jp
Sponsor or person
Institute
Bukkyo University
Institute
Department
Personal name
Funding Source
Organization
Bukkyo 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
Bukkyo University Human Research Ethics Review Committee
Address
96 Hananobo, Kita-ku Murasakinokita, Kyoto, Kyoto
Tel
075-491-2141
gakusien@bukkyo-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 | 02 | Month | 28 | 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
22
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
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 20 | 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 | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065361
