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Open-label, non-randomized, prospective, single-center, self-controlled clinical study.
Eligible subjects will be divided into two groups. The test group will include 15-22 subjects who will be treated to revive their body's functional potential, and the control group will include 15-22 subjects, who will not be treated.
The Test group will arrive to 6 Pure Impact sessions and to 4 weeks follow-up visit; while the control group will arrive to 3 visits, which are equivalent to before first treatment, last treatment (5 weeks after first visit) and 4 weeks after the second visit (equivalent to 4 weeks follow-up visit of the test group).
Subjects of the test group will receive 6 Pure Impact treatments on the abdomen and quadriceps, and/or hamstring and glutes once a week.
First treatment may be administered after the enrolment and screening at the first visit, or it may occur later following the enrolment and screening activities based on site scheduling availabilities.
Overall, all treatments are done within 6 weeks.
All subjects will return to the clinic for follow-up visit at 4±1 weeks post last treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Muscle strength | Experimental | Pure Impact is an EMS module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. |
|
| Control | No Intervention | Control group will be followed but will not be treated. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pure Impact | Device | Pure Impact is an EMS module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate of the muscles strength | Higher improvement rate of the muscles strength tests at the test group compared to the control group using series of exercises tests including questionnaire, and a functional evaluation of the muscles of the abdomen, quadriceps, and glutes. | 1 Month post last treatment follow up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shlomit Mann, MSc | Contact | 047800268 | shlomit@sofwave.com | |
| Ruthie Amir, MD | Contact | 043003164 | ruthie@sofwave.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahlam Safadi, BSC | Sofwave Medical LTD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Movassaghi Plastic Surgery & Ziba Medical Spa | Recruiting | Eugene | Oregon | 97401 | United States |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |