Pure Impact Treatment to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-60
SponsorSofwave Medical LTD
About this trial
Open-label, non-randomized, prospective, single-center, self-controlled clinical study.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female subjects ≥ 25 years of age and ≤ 60 years of age.
Not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide) or abstinence.
Desire to undergo treatments on abdomen and quadriceps and/or on hamstring and glutes for strength and tone muscles.
Subject agrees to maintain their weight within 5% of total body weight and avoid significant dietary or exercise changes during the study.
Disqualifiers
Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
Medical disorder that would hinder the wound healing or immune response (such as blood disorder) including but not limited to arterial circulation disorders in lower limbs, inflammatory disease, etc.
Active malignancy or history of malignancy in the past 5 years.
Suffering from significant concurrent illness, such as cardiac disorders, sensory disturbances, diabetes (type I or II), epilepsy, lupus, porphyria, pertinent neurological disorders, uncontrolled hypertension, or liver or kidney disease (i.e. any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process).
Trial design
Design model
Parallel
Treatments tested in this trial
Pure Impact
DevicePure 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.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Muscle strengthExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
1 Month post last treatment follow up visitSponsors and contacts
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Source ClinicalTrials.gov