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

To perform a preliminary usability evaluation of a novel, compact pneumatic compression device in patients with lymphoedema.

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.

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.

The new pneumatic compression device fitted well, was easy to use and reduced leg oedema.