Background and Objectives: The recovery of stroke patients with severe impairment is usually poor and limited and, unfortunately, under-investigated in clinical studies. In order to support neuroplasticity and modulate motor recovery, Cerebrolysin combined with rehabilitation treatment has proven effective in the acute stroke phase in moderate to severe motor impairment. The aim of this study was to determine the efficacy of extended poststroke rehabilitation combined with Cerebrolysin on upper limb motor recovery in subacute stroke patients with severe upper limb motor impairment. Materials and Methods: A randomized, double-blind, placebo-controlled study was conducted. Sixty patients at the early stage of severe sub-acute stroke who fulfilled all eligibility criteria were randomly assigned to the Cerebrolysin group or placebo group (𝑛 = 30 each). Both groups, after conducting three weeks of conventional rehabilitation treatment five days per week, continued to perform conventional rehabilitation treatment three times per week until 90 days of rehabilitation treatment. The primary outcome measure was the Action Research Arm Test (ARAT), and the secondary outcomes were the Fugl-Meyer Assessment-Upper Extremity (FMA-UE) motor score, Barthel index (BI), and the National Institutes of Health Stroke Scale (NIHSS). The outcome data were evaluated before, after three weeks of treatment, and on the 90th day of rehabilitation treatment, and compared within groups and between the two groups. There were no adverse events. Results: Both groups showed a significant improvement (p < 0.001) over time in BI, FMA-UE, ARAT, and NIHSS scores. Patients receiving Cerebrolysin showed more significant improvement in post-stroke upper limb motor impairment and functioning compared to the placebo group after only three weeks, and the trend was maintained after 90 days of follow up. Conclusion: Cerebrolysin delivered in the early subacute post-stroke phase added to extended conventional rehabilitation treatment is beneficial and improves motor functional recovery in patients with severe motor impairment, especially on the paretic upper extremity.
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