Pedal Pump Clinical Trial on Edema V1
David McVay
Summary
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. Key Question for this first 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.
Description
The Pedal Pump is a device which engages the feet of patients while they are in bed. The device is placed between the foot board and the patient's feet. It provides gentle, on-and-off pressure to the feet, which, in turn, mobilizes the whole body in a rhythmic, calming manner. The proposed hypotheses of the Pedal Pump are primarily based on the health benefits provided by normal walking. They include, but are not limited to… Physiological Benefits * Increase lymphatic flow within the body * Increase blood flow back to the heart and into the tissues * Increase intestinal peristalsis * Increa…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Bilateral lower extremity edema of at least mild severity judged by the treating clinician to be due to CHF, chronic venous insufficiency, kidney disease, or other etiologies of fluid overload conditions. * Medically stable * Able to remain in Fowler position for 10 minutes * Patients in the ER, observation, or admitted to the hospital for any period of time; outpatients (specifically CHF clinic patients) * Patients must give informed consent to participate. The patient must be able to read the consent form (in English or Spanish) or give consent after the form is transl…
Interventions
- DevicePedal Pump
The Pedal Pump device pumps both feet for 10 minutes continuously-- mobilizing their whole body in sufficient manner to see the nose move.
- DevicePedal Pump Sham
The Sham Intervention is the same as Pedal Pump Intervention with the exact same Pedal Pump device generating identical operational sounds and visible movement; however, 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.
Location
- Hillcrest Medical CenterTulsa, Oklahoma