Usability evaluation of a novel compact pneumatic compression device for the treatment of lymphoedema: Pilot study

Objective: To perform a preliminary usability evaluation of a novel, compact pneumatic compression device in patients with lymphoedema. Methods: This open-label, single-arm trial had two phases: the first focused on the fitting of the pneumatic compression device (Aria Free (TM), Aria Health, San Diego CA, USA) and the second focused on evaluating the comfort of the entire system during a 45-min usage period. Both phases were conducted in a monitored clinical environment. Patients aged >= 18 years with a diagnosis of lower limb lymphoedema who had used a pneumatic compression device for >= 3 months were eligible. Patients rated subjective fit, comfort and usability on an 11-point Likert scale (where higher scores indicate better fit/comfort/usability). The truncated cone method was used to infer limb volume before and after therapy in phase 2. Results: Twenty-four patients were screened, and 15 were enrolled (80% female; mean age 62 years); all completed both study phases. Patients rated the garment as easy to set up and fit (median score 6.5), and all reported that the therapy was comfortable (median score 10; p < 0.001 vs. reference score of 6). There was a 1.85% reduction in limb volume after device use for 45 min (p = 0.018 vs. before therapy). No safety issues were identified. Conclusions: The new pneumatic compression device fitted well, was easy to use and reduced leg oedema.