Application of Bedside Lower Extremity Rehabilitation Robots in Stroke Rehabilitation: A Randomized Controlled Trial.

Stroke remains one of the leading causes of disability worldwide. Bedside lower limb rehabilitation robots are increasingly applied to enhance early motor recovery. This randomized controlled trial compared the clinical efficacy and patient comfort of robot-assisted therapy versus conventional manual therapy in post-stroke hemiplegia. Forty inpatients with first-onset stroke and lower limb muscle strength ≤ grade 2 were randomly allocated (1:1) to a robot-assisted therapy group or a conventional manual therapy group using SAS 9.4 (SEED = 12345). This randomized controlled trial compared the clinical efficacy and patient comfort of robot-assisted therapy versus conventional manual therapy in post-stroke hemiplegia, with primary outcomes including the General Comfort Questionnaire (GCQ), Fugl-Meyer Assessment for lower extremities (FMA-LE), Modified Ashworth Scale (MAS), and Modified Barthel Index (MBI). Robot-assisted therapy achieved similar early motor gains, superior comfort scores, and greater later functional improvements compared to conventional manual therapy. Integrating bedside rehabilitation robots into early stroke care is feasible, safe, and may enhance patient experience and functional recovery. This protocol describes a two-stage intervention design, where the robot-assisted group received a combination of robot training and artificial therapy in the later stage.