UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057614 |
|---|---|
| Receipt number | R000065828 |
| Scientific Title | Effects of 448 kHz electrical stimulation on rectus femoris stiffness and intramuscular hemodynamics |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2025/04/15 10:38:13 |
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Basic information
Public title
Effects of 448 kHz electrical stimulation on rectus femoris stiffness and intramuscular hemodynamics
Acronym
Effects of high-frequency electrical stimulation on stiffness and blood flow in the rectus femoris muscle
Scientific Title
Effects of 448 kHz electrical stimulation on rectus femoris stiffness and intramuscular hemodynamics
Scientific Title:Acronym
Effects of High Frequency Electrical Stimulation on Rectus Femoris Stiffness and Blood Flow
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of electrical stimulation using 448 kHz on rectus femoris stickiness and hemodynamics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following outcomes will be evaluated before and after each intervention (immediate effect) in the high-frequency electrical stimulation, hot pack, and Sham conditions
(1) Rectus femoris muscle stiffness (ultrasound imaging device)
(2) Intramuscular hemodynamics (near-infrared light)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
448 kHz electrical stimulation
Interventions/Control_2
Hot pack
Interventions/Control_3
pseudothermal stimulation
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
Female
Key inclusion criteria
Healthy adult females
Key exclusion criteria
Those with orthopedic diseases such as muscle injury or fracture in the thigh in the past year
History of central nervous system disease or peripheral nerve disease
History of cardiac disease
History of cardiac pacemaker implant
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | takayuki |
| Last name | Miyamori |
Organization
Juntendo University
Division name
Postgraduate School of Health and Sports Science
Zip code
113-8421
Address
2-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL
0338121780
t.miyamori.hi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Miyamori |
Organization
Juntendo University
Division name
Postgraduate School of Health and Sports Science
Zip code
113-8421
Address
2-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL
08097733123
Homepage URL
t.miyamori.hi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo 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
Juntendo University
Address
2-1-1 Hongo Bunkyo-ku Tokyo
Tel
0338121780
t.miyamori.hi@juntendo.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 | 04 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | 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 | 04 | Month | 15 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065828
