The Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life With Adults on Hemodialysis
For the ESRD patients undergoing hemodialysis treatment, specifically, reflex mediated calf muscle pump stimulation has the potential to significantly reduce the number and magnitude of hypotensive episodes thus enhancing the effectiveness of the dialysis process. Fewer hemodialysis complications during the patient's hemodialysis treatment, would allow treatment sessions to continue to the prescribed volume removal, with much reduced patient recovery time, and the costs associated with this recovery.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||the Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life|
- Effects of Plantar Stimulation on Hypotension during Hemodialysis With Adults [ Time Frame: 4 hour treatments ] [ Designated as safety issue: No ]
- Effects of Plantar Stimulation on Treatment Efficacy With Adults on Hemodialysis [ Time Frame: 4 hour treatment ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||January 2009|
|Estimated Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Device: Effects of Plantar Stimulation
Use of a low-intensity mechanical stimulus to the plantar surface (sole) so as to trigger a reflex response causing soleus muscle contraction, and thereby an increase in calf muscle pump activity. The plantar stimulation device (VStim; Juvent Medical Inc., Somerset, NJ) delivers a 50 micrometer displacement to the plantar surface of the foot at 45 Hz. This device has been shown to significantly increase lower limb blood and lymphatic flow when patients use the device while in a seated or supine position.