Introduction: Very early mobilization (VEM) is thought to be beneficial for stroke-unit care, but many key factors, such as initiation time and intensity, have not been optimized. We attempted to determine an optimal mobilization plan with well-defined initiation time and intensity in clinical practice.
Methods: We conducted a randomized controlled trial with blinded assessment at follow-up. Patients with ischemic stroke, first or recurrent, admitted to the stroke unit within 24 h of stroke onset who met physiological criteria were randomly assigned (1:1:1) to 3 groups: Routine Mobilization (RM) received a lower dose of out-of-bed mobilization (<1.5h/d) 24-48 h post-stroke, Very Early and Intensive Mobilization (VEIM) received a higher dose of out-of-bed mobilization (≥3h/d) within 24 h, and Early and Intensive Mobilization (EIM) received a higher dose of out-of-bed mobilization (≥3h/d) 24-48 h post-stroke. Out-of-bed mobilization involves sitting, standing, and walking with or without assistance. The intervention period lasted 10-14 days. All the patients received standard medical therapy according to their different conditions. Patient function was evaluated with the modified Rankin Scale (mRS) score at discharge, 3 months after, and 6 months after. The primary target was a favorable outcome at follow-up, defined as an mRS score of 0-2. We used the Friedman test and the chi-squared test on a fourfold table for significance.
Results: A total of 150 patients were recruited, and 120 (80%) finished the training and follow-up assessment with 30 patients dropping out (10 in RM, 12 in VEIM and 8 in EIM). Patients receiving VEIM had lower odds of a favorable outcome at both 3 and 6 months, although the difference did not reach the p = 0.05 level of significance. In the VEIM group, only 42.1% of patients had a favorable outcome 6 months after discharge, as opposed to 55.0% of RM patients and 61.9% of EIM patients.
Conclusions: The higher dose mobilization protocol started within 24 h post-stroke was not associated with an increase of favorable outcomes at both 3 and 6 months post-discharge, but rather with a trend toward poorer outcomes. However, the higher dose mobilization protocol started within 48 h post-stroke may lead to a better outcome.