Pedal Pump Clinical Trial on Edema V2

Condition(s) studied

Investigational drug(s) / intervention(s)

Pedal Pump: The Pedal Pump device pumps both feet for 10 minutes continuously-- mobilizing their whole body in sufficient manner to see the nose move.

Pedal 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.

Study 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, 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.

Eligibility

Primary outcome measure(s)

• Treatment Tolerability in at least 19 of the 20 patients in the Pedal Pump treatment group — 10 minutes
  ≥95% of the subjects receiving the Pedal Pump treatment finished the 10 minutes of treatment without stopping it because of adverse effects (\<5% "aborted" treatments).

Trial sites (1)

Other trials for the same condition