Efficacy and feasibility of Intradialytic Plantar Electrical Stimulation in patients with diabetes: A Randomized Double-Blind Controlled Trial

<p dir="ltr">OBJECTIVE</p><p dir="ltr">This study investigates the efficacy and feasibility of electrical stimulation (E-Stim) on sensory fibers of the plantar region during hemodialysis (HD) sessions, aiming to improve mobility in diabetes patients by providing a connection between electrical stimulation and enhanced mobility with minimal patient effort required.</p><p dir="ltr">RESEARCH DESIGN AND METHODS</p><p dir="ltr">Participants 18 and above, undergoing HD in the diabetes patients, and able to walk at least 10 meters with or without aid, were recruited and divided into an intervention group (IG) receiving 1-hour intradialytic E-Stim 3 times/week, and a control group (CG) using an identical non-functional device, for 12-week. Gait, physical activity, patient-reported outcomes, and the technology acceptance model were assessed to evaluate the intervention's effectiveness and acceptance.</p><p dir="ltr">RESULTS</p><p dir="ltr">Out of 117 initial participants, 97 completed the study. Significant improvements were observed in the IG compared to the CG in gait performance (stride time at dual-task and fast walking), physical activity (stand-to-walk and sit-to-stand), quality of life, plantar numbness, and cognitive function after 12-week. The IG showed magnitude of improvements on gait performance and physical activity metrics are associated with enhancements on quality of life and cognitive function, respectively. The IG also reported higher 'usefulness' and 'usage satisfaction', with a greater willingness to continue using E-Stim at home.</p><p dir="ltr">CONCLUSIONS</p><p dir="ltr">The 12-week intradialytic E-Stim intervention is a feasible and effective method to enhance gait performance, physical activity level, cognitive function and other patient-reported outcomes in HD patients, representing a practical, low-risk therapy option for those unable to engage in traditional exercise programs.</p>