UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059074 |
|---|---|
| Receipt number | R000067493 |
| Scientific Title | Verification of the Muscle Relaxation Effect of Palm G-Point Stimulation Using a Developed Stimulation Device |
| Date of disclosure of the study information | 2025/09/12 |
| Last modified on | 2025/09/12 16:25:05 |
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Basic information
Public title
Verification of the Muscle Relaxation Effect of Palm G-Point Stimulation Using a Developed Stimulation Device
Acronym
Verification of the Muscle Relaxation Effect of Palm G-Point Stimulation Using a Developed Stimulation Device
Scientific Title
Verification of the Muscle Relaxation Effect of Palm G-Point Stimulation Using a Developed Stimulation Device
Scientific Title:Acronym
Verification of the Muscle Relaxation Effect of Palm G-Point Stimulation Using a Developed Stimulation Device
Region
| Japan |
Condition
Condition
Healthy adults and older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify, through a crossover design, whether stimulation of the G-point on the palm using a stimulation device (grip) developed as a health device can bring about a muscle relaxation effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Standing forward flexion distance (cm): comparison between the developed stimulation device condition and the dummy device condition, 5 minutes after the start of the intervention.
Key secondary outcomes
Shoulder muscle stiffness: comparison between the developed stimulation device condition and the dummy device condition, assessed before and after the intervention (following standing forward flexion measurements).
Subjective evaluation of ease of movement (questionnaire): comparison between the developed stimulation device condition and the dummy device condition, assessed after the completion of the test.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Developed stimulation device (stimulation) - Washout - Dummy device (no stimulation)
Interventions/Control_2
Dummy device (no stimulation) - Washout - Developed stimulation device (stimulation)
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy Japanese males and females who are aged 20 to under 70 years at the time of written informed consent.
2. Subjects who have been fully informed the purpose and details of the study, have the ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing.
Subjects who bend forward and cannot firmly touch the front of their palms to the floor.
3. Subjects who can come to the facility on the designated test date and take the test.
4. Subjects who bend forward and cannot firmly touch the front of their palms to the floor.
5. Subjects who are healthy enough to exercise.
Key exclusion criteria
1.Subjects with chronic diseases associated with exercise restrictions, or those currently receiving treatment for any diseases.
2.Subjects with a history or current diagnosis of chronic fatigue syndrome with exercise restrictions, psychiatric disorders, sleep disorders, hypertension, diabetes, dyslipidemia, or other serious diseases.
3.Subjects with a history or current diagnosis of low back pain or spinal disorders (e.g., herniated disc, spinal canal stenosis).
4.Subjects with a history or current diagnosis of severe cardiovascular, respiratory, hepatic, renal, hematologic, or gastrointestinal disorders that may adversely affect health during exercise.
5.Subjects with severe anemia.
6.Subjects who have continuously used medications (oral or topical) for disease treatment within the past month.
7.Subjects with a body mass index (BMI) exceeding 30.
8.Subjects with potential allergies to materials (e.g., plastic) used in the device.
9.Subjects with irregular lifestyles due to shift work or night work.
10.Subjects who are currently participating in another clinical trial, or who have participated in another clinical trial within the past three months.
11.Subjects who are pregnant, breastfeeding, have the potential to become pregnant, or intend to become pregnant during the study period.
12.Subjects who are judged as ineligible to participate in this study by the principal investigator.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hisayo |
| Middle name | |
| Last name | Sugao |
Organization
LEMON inc.
Division name
Research and Development Division, Headquarters
Zip code
104-0031
Address
3-6-10 Kyobashi, Chuo-ku, Tokyo
TEL
080-2923-9987
sugaohisayo@lemonkk.co.jp
Public contact
Name of contact person
| 1st name | Hisayo |
| Middle name | |
| Last name | Sugao |
Organization
LEMON inc.
Division name
Research and Development Division, Headquarters
Zip code
104-0031
Address
3-6-10 Kyobashi, Chuo-ku, Tokyo
TEL
080-2923-9987
Homepage URL
sugaohisayo@lemonkk.co.jp
Sponsor or person
Institute
LEMON inc.
Institute
Department
Personal name
Funding Source
Organization
LEMON inc.
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
03-6240-1162
info@ueno-asagao.clinic
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 | 12 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 25 | 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 | 12 | Day |
Last modified on
| 2025 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067493
