The Safety And Effect Of Early Mobilization For Acute Stroke

Objectives:To investigate the safety and effect of early mobilization (EM) with an emphasis on mobilization in 72 hours after stroke onset, and further more to explore the maximum activity amounts and frequencies in the acute stage of stroke patients. Materials andmethods:A randomized controlled trial with blinded outcome assessment was performed. First, we prospectively registered the consecutive admitted stroke patients in the department of neurology of our hospital from April 2008 to August 2009. Diagnostic criteria:Used (WHO) criteria for stroke and confirmed by CT/MRI (subarachnoid hemorrhage had been excluded). Inclusion Criteria:(1). Patients with ischemic or hemorrhagic stroke within 72 hours of symptom onset; (2)Patients with the age from 18 to 80; (3) Patients with hemiplegic and stable blood pressure, and also need the help of others for active daily living(ADL).We used computer-generated random number and opaque envelops concealed the allocation protocol. Patients were randomly assigned to early mobilization (EM) or control (delayed mobilization; DM) group. Both group received the same standard care. For EM group, we asked the patients to mobilize as earlier as possible and try the best to mobilize more frequently until discharge when the patient was included. For control group, we gave the same suggestion after 7 days of the stroke onset. Primary outcome measurements included the mortality, the poor outcome (death/dependence) and serious adverse events at the end of follow-up (1,3,6,12 months). Secondary outcome measurements included(1)The neuro-function by Scandinavian Stroke Scale (SSS) at 3,5,7,10 days of stroke onset.(2)the occurrence of complication at the end of follow-up. (3)The time from stroke onset to first mobilization for each group. (4)The total dose of mobilization (activity amounts and frequencies) at the first week of recruited (1st,3rd,5th and 7th days after recruited).Statistical Analyses:T-test were used in measurement data (data normally distributed). Chi-square test were used in count data. Intention-to-Treat was used for lost follow-up patients. Results:1. The eligible 120 cases were included from 957consecutive patients in our hospital during 17 months period (from April 2008 to August 2009). (EM 69; DM 51); 80 cases (66.67%)were ischemic stroke,40 cases (33.33%) were hemorrhagic stroke; The group mean±SD age was 62.5±11.1 years; 68 cases were male(56.67%), the ratio of male/female was 1.31.2 The baseline data in each group were closely similar in all important prognostic variables (P>0.05).3.Primary outcomes:①The mortality of patients in EM group were lower than the control group at the end of 1,3,6,12 months, but there were no statistically difference in the two groups. (the number of death in the EM group at the end of the 1st month was 0, and the control group was 1; The mortality of patients in EM group and the control group at the end of 3,6,12 months was 1.45% and 3.92%(P=0.391),2.90% and 5.88%(P=0.419),2.90% and 9.80% (P=0.111) respectively.②The cases of serious adverse events in the two groups were similar.③The cases of poor outcome in EM group were more than that in the DM group at the end of the 1st month (EM,44 of 69 vs DM,28 of 51, P=0.327). At the end of the 3rd,6th,12th month, there were significantly fewer poor outcomes experienced by patients in the EM group(P<0.05).According to the score of mRS, compared to the DM group, the risk of EM group were 39.8%(OR 0.398, 95%CI 0.189-0.836, P=0.014),29.0%(OR 0.290,95%CI=0.133～0.635, P=0.002),34.7%(OR 0.347,95%CI=0.133～0.905, P=0.026) respectively; and according to the score of BI, compared to the DM group,the risk of EM group were 41.5%(OR 0.415,95%CI 0.198～0.871,P=0.019),28.8%(OR 0.288,95%CI 0.134-0.620,P=0.001),39.6%(OR 0.396,95%CI 0.156～1.007,P=0.047) respectively 4.Secondary Outcomes:①At the end of the 1st,3rd,6th month, the complications of patients in the two groups were similar, but there were no statistically difference existed.②There was statistically difference existed of the times from stroke onset to initial mobilization in the two groups (EM group 44.74±9.7h vs DM group 53.69±7.25h; P<0.01).③There was no statistically difference of the total dose of mobilization (activity amount and frequency) in the two groups at the first week after included (P>0.05). Conclusions:EM of patients within 72 hours of acute stroke appears safe. EM can reduce the poor outcomes (death/disability) at the end of 3,6,12months; The best activity amounts and frequencies for acute stroke are not clear and need further study. Objectives:To investigate the effect of early mobilization for the emotion of anxiety and depression in the acute stroke patients. Materials and methods:when registering materials of the 1st part, we did the assessment of self-rating anxiety scale(SAS) and self-rating depression scale(SDS) for the last included 30 cases at the first week before stroke onset and one week,the 1st m,3rd m,6th m after stroke. Outcome Measurements:The occurrence of anxiety and depression for the two group patients at the end of 1st,3rd,6th month. Statistical Analyses:Chi-square test were used for count data (Fisher's exact test was used in our study).Results:Thirty cases were included. There was one case lost follow-up and one death in the control group at 1 month, so 28 cases were assessed.16 cases (57.14%) were ischemic stroke,12 cases (42.86%)were hemorrhagic stroke; age from 18 to 80 (63.5±8.0 y),15 cases were male(53.57%),13 cases were female(46.43%). There was no significant difference of baseline characteristics (P>0.05). The numbers of anxiety patients in the early mobilization (EM)group were lower than that in the control group at the end of 1st week,1st m,3rd m,6th m, but there were no statistically significant difference existed. Compared to the control group,the risk of anxiety occurrence in EM group at the end of 1st week,1st m,3rd m,6th m were 34.7%(OR 0.347,95%CI 0.072～1.686, P=0.248),20.5%(OR 0.205,95%CI 0.039～1.074,P=0.120),25.7% (OR 0.257,95%CI 0.046～1.438,P=0.200),28.1%(OR 0.281,95%CI 0.022～3.550, P=0.543); Compared to the control group, the risk of depression occurrence in EM group at the end of 1st w,1st m,3rd m,6th m were 23.3%(OR 0.233,95%CI 0.034-1.591,P=0.174),17.9%(OR 0.179,95%CI 0.032～0.999,P=0.095),15.6%(OR 0.156,95%CI 0.029～0.845,P=0.051),23.3%(OR 0.233,95%CI 0.034-1.591,P=0.174)Conclusions:EM has a tendency of decreasing the occurrence of anxiety and depression in the acute stroke patients. Because of the small sample size in this study, further study will be needed.