3. Results
post-stroke hemiparesis
ADVERSE EVENTS
One hundred and twelve patients with severe post-stroke hemiparesis were screened for eligibility criteria. Sixty patients fulfilled all eligibility criteria. Twenty-seven did not meet the inclusion criteria, thirteen patients were medically unstable, and twelve declined to participate in the clinical trial. There were no significant differences in baseline demographic and clinical parameters between groups. Descriptive statistics of all outcomes in both groups are presented in Thirty participants were included in each group. There was no statistically significant difference in sex (The results of testing the changes in the outcome measures (NIHSS, BI, FMA-UE, and ARAT) over time are presented in There is a statistically significant two-way interaction between the type of therapy and time for all outcomes (NIHSS: F (2.58) = 56.1, The changes in outcome measures over time at each level of treatment are statistically significant in all outcomes for the Cerebrolysin group (The changes in the outcome measures over time at each level of treatment are statistically significant in all outcomes (At different time points, all tested parameters differed significantly in the Cerebrolysin group. The BI, FMA-UE, and ARAT were statistically significantly higher (BI: < 0.0001; FMA-UE: The changes in the outcome measures over time at each level of treatment were statistically significant in all outcomes for the placebo group (At different time points, all tested parameters differed significantly in the placebo group. BI, FMA-UE, and ARAT were statistically significantly higher (BI: Both groups showed a significant improvement over time in the BI, FMA-UE, ARAT, and NIHSS scores. However, the participants receiving Cerebrolysin therapy made more significant improvement than participants in the placebo group (The significant improvement between two time points in all outcomes of both groups, separately, is presented in Statistically significant differences were shown between the Cerebrolysin and placebo groups in all tested parameters at different time points (NIHSS: pre–post: The comparisons in time points between groups in NIHSS score, Barthel index, FMA-UE and ARAT are presented in There is no statistically significant difference between groups in the Barthel Index in time point post. All other comparisons between groups are statistically significant with a large effect size, except the NIHSS score with a medium effect size.No adverse events were registered in either group during or after the application or until the end of the study. No participant dropped out of the study. 