The fourier M2 robotic machine combined with occupational therapy on post-stroke upper limb function and independence-related quality of life: A randomized clinical trial

Most post-stroke patients experience upper limb functionality challenges. Emergent therapies using upper limb-based robot machines present opportunities to resolve the limitations inherent in Occupational therapy such as increased therapist-patient exhaustion, monotonous methods, and so forth. The aim of this parallel trial was to compare the effects of the upper limb robotic training with matched Occupational therapy training on upper limb function and independence-related quality of life in post-stroke patients within the Brunnstrom arm motor recovery stages 1 to 4. During one-year (2018-2019), 50 post-stroke patients were enrolled and randomly assigned to 2 groups; robot and Occupational therapy (n = 25) and Occupational therapy (n = 25). Both groups were trained for 50-70 minutes per day, 5 days a week for 6 weeks. The Chinese-adapted Fugl-Meyer Assessment-Upper Extremity (FMA-UE) was the primary outcome measure. The secondary outcome measures were the Brunnstrom Recovery Stages Scale (BRS) and the Chinese-adapted Barthel Index (BI). The treatment effect sizes of both groups were large in the following variables; transfers (1), BI total score (2.2), FMA-UE upper limb (1.1), wrist (1.8), elbow (1), fingers (0.9), and FMA-UE total scores (1.4). The treatment group in comparison to the control group had larger BRS changes, significant improvements in upper limb function, and partial independence in activities of daily living during the baseline to post-treatment period. Robotic-assisted training with occupational therapy may improve the upper limb movement foundation blocks; however, it does not translate into complete functional independence and improved quality of life. This study has been registered at the ISRCTN registry, https://doi.org/10.1186/ISRCTN84804731.