Rehabilitation with Brain-Computer Interface and Upper Limb Motor Function in Ischemic Stroke: A Randomized Controlled Trial
第一作者:Anxin Wang,Xue Tian
通讯作者:Xia Meng
2024-06-14
Upper limb motor dysfunction is a major problem in the rehabilitation of stroke patients. Brain-Computer Interface (BCI) is a kind of communication system which converts the "ideas" in the brain into instructions and has been used in stroke rehabilitation.
The BCI accuracy calculation method was calculated once per trial, and was determined by the ratio of the total number of correctly identified trials to the overall number of trials conducted. Baseline characteristics between the groups were compared. Continuous variables were presented as mean with standard deviation or median with inter-quartile range according to the data distribution and compared using Student’s t-test or Wilcoxon test as appropriate. Categorical variables were presented as frequencies with percentages and compared using the chi-squared test. Efficacy analyses were performed in the intention-to-treat population. Differences between treatment groups in changes of FMA-UE from baseline to 1 month after rehabilitation were calculated as mean differences with 95% confidence intervals (CIs) and were compared using generalized linear model with the formula of outcome~group. Similar approaches were used for comparison of the secondary outcomes of changes in ARAT, WMFT, IADL, and MAS. Differences between treatment groups in the incidence of safety outcomes within 3-month follow-up were compared with chi-squared test or Fisher’s exact test. In addition, sensitivity analyses for the primary outcome were performed by considering clinical sites as a random effect with a generalized linear mixed model and by adjusting for baseline scores. The treatment effects were analyzed among subgroups by testing the treatment-by-subgroup interaction effect. Differences in MCID values of outcomes were compared with logistic regression. All of the tests were two-sided, and a P-value of 0.05 was considered to indicate statistical significance. All statistical analyses were performed using SAS software, version 9.4 (SAS Institute Inc., Cary, NC, USA).