HIFEM and Radiofrequency for Muscle Weakness

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: BTL Industries Ltd.

Trial Summary

What is the purpose of this trial?The goal of this clinical trial is to investigate the effect of the BTL-899M device on muscular system function in adult subjects seeking treatment for improving their muscular system function in the lower extremities. The main question it aims to answer is: Whether the BTL-899M device is effective for muscular system function improvement 3 months posttreatment compared to the sham group, based on the dynamometer measurement. Researchers will compare a sham group to see if the device is effective. Participants will complete four treatment visits and two follow-up visits. Their strength will be recorded via a dynamometer.

Eligibility Criteria

This trial is for adults seeking to improve muscle function in their lower extremities, possibly due to conditions like pediatric hemiparesis or general muscular weakness. Participants must be able to attend four treatment and two follow-up visits.

Inclusion Criteria

I am 22 years old or older.

I agree not to undergo any treatments outside the study for my musculoskeletal system.

Exclusion Criteria

I have a contagious skin condition.

I have trouble breathing or lung problems.

I have Graves' disease.

I have issues with feeling temperature or pain.

I do not have any ongoing infections like TB or bone infection.

I have metal implants in my body.

I have a cancerous tumor.

I have a bleeding condition or I'm on blood thinners.

I do not have an infection in my blood or pus in the pleural space of my lungs.

I am currently experiencing an acute inflammation.

Treatment Details

The study tests the BTL-899M device's effectiveness on muscle function. One group receives actual treatment while a sham (placebo) group gets non-therapeutic intensity treatments. Muscle strength is measured with a dynamometer three months post-treatment.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment with BTL-899MExperimental Treatment1 Intervention

Four (4) BTL-899M treatments will be applied to the lower extremities.

Group II: Treatment with BTL-899M with intensities below therapeutic thresholdPlacebo Group1 Intervention

Four (4) BTL-899M treatments will be applied to the lower extremities, with intensities below therapeutic threshold