Pedal Pump for Swelling in the Legs
What You Need to Know Before You Apply
What is the purpose of this trial?
Previous research on the osteopathic manual technique entitled "Pedal Pump" has shown health benefits, specifically increasing lymphatic flow, decreasing lower extremity edema, and decreasing serum lactic acid after maximal exercise. However, due to the limitation of human practitioners, research has been limited.
The Pedal Pump is now a device which facilitates consistency in treatment and allows for increased sample size in research. This clinical trial studies the effects of 10 minutes of Pedal Pump treatment for hospitalized patients with lower extremity edema, almost the same as Pedal Pump Clinical Trial on Edema V1 that is underway; however, this study focuses primarily on the objective data gathered by trained Occupational Therapists who regularly measure lower extremities.
Key Question for this second study: Is the Pedal Pump a feasible treatment for hospitalized patients? Secondary question: Does the Pedal Pump decrease lower extremity edema?
This is a novel idea in its early stage of development, so Investigators anticipate product advancements, further testing with larger population sizes, and future publications.
Are You a Good Fit for This Trial?
This trial is for hospitalized patients who have swelling in their legs, often due to heart failure or chronic venous insufficiency. People with other serious conditions that could interfere with the study may not be able to participate.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Pedal Pump
Trial Overview
The study compares a device called the Pedal Pump, which gently moves the feet to help reduce leg swelling, against a sham (inactive) version of the same treatment. Each session lasts about 10 minutes and effects are measured by occupational therapists.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
The Treatment group will experience the Pedal Pump intervention by... * Being assisted to sit up in their beds at a 45-60 degree Fowler's position. Their thighs, calves, and ankles being marked with a surgical marker at the locations and measured. * The heel protector pillows being attached to their feet and the Pedal Pump being placed at the foot of the bed. * Provided the treatment is tolerated by the patient, the Pedal Pump treatment being applied to both feet for 10 minutes continuously mobilizing their whole body in sufficient manner to see the nose move. * The Operator turning off the device and removing it from the bed.
The Sham Group will have the same experience as Treatment Group with the exact same device generating identical operational sounds and visible movement, but the patient's body will not be close enough to the device to produce sufficient displacement to transmit mechanical forces beyond the feet. The Pedal Pump will only contact the heel protector pillows enough to make the toes move but will not contact them enough to mobilize the legs or the entire body.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hillcrest
Lead Sponsor
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