The Effect of Early Mobilization in Mild to Moderate Hemorrhagic Stroke
Condition: Hemorrhagic Stroke
MeSH terms: Stroke; Hemorrhagic Stroke
Study type: Interventional

Summary: 
      This study aims to examine the outcomes of early mobilization and early intervention within
      24-72 hours after the onset of hemorrhagic stroke in patients admitted to an intensive care
      unit within 24 hours after stroke. The patients after hemorrhagic stroke who undergo early
      intervention only will be compared with those who also receive early mobilization in order to
      determine if the early mobilization intervention results in earlier or more effective
      recovery of postural stability, activities of daily living function, or motor capacity.

      The participants will be randomly assigned to the following two groups: (1) the early
      mobilization (+early rehabilitation) group and (2) the early rehabilitation group.The
      measurement parameters will be collected before the intervention (basic parameters), two
      weeks after the stroke, four weeks after the stroke and three months after the stroke. SPSS
      (version 17.0) will be used to carry out repeated measures analysis of variance (repeated
      ANOVA) to compare the differences between the groups at different time points (including
      basic values and follow-up values). For statistical significance, Bonferroni correction will
      be applied for the post-hoc analysis of the groups.
    

Detailed description: 
      Early intervention has been proven to enhance post-stroke functional recovery. Recent studies
      have proposed that early mobilization (out-of-bed activities) also contributes to an
      individual's functional improvement after stroke. However, studies on early intervention
      after stroke have mainly investigated patients with ischemic stroke, while tending to exclude
      patients with hemorrhagic stroke who were admitted to intensive care units. The main reason
      for this is the difference between hemorrhagic and ischemic strokes in terms of their
      mechanisms and treatment methods. Hemorrhagic stroke is characterized by higher severity and
      fatality rates, and there is a general lack of research on early rehabilitation and
      mobilization after hemorrhagic strokes. To our knowledge, there have been no previous studies
      that have simultaneously compared the impact of early mobilization and early rehabilitation
      starting at the same time on the motor recovery of patients after intracranial hemorrhage.
      Thus, this study aims to examine the outcomes of early mobilization and intervention within
      24-72 hours after the onset of hemorrhagic stroke in patients admitted to an intensive care
      unit within 24 hours after stroke. The patients will be compared to identify differences in
      the recovery of postural stability and functional abilities two weeks, four weeks and three
      months after stroke.

      The participants will be randomly assigned to the following two groups: (1) the early
      mobilization (+early rehabilitation) group and (2) the early rehabilitation group. The early
      mobilization group will receive early mobilization intervention within24-72 hours after
      stroke while being monitored by medical equipment. In early mobilization group, this
      intervention program will most include early out-of-bed activities (that is, rolling and
      sitting at the edge of the bed). The early rehabilitation group will undergo only
      conventional early in-bed activities in the stroke center.

      All the outcome measures will be collected at baseline (pre-intervention), 2 weeks after
      stroke, 4 weeks after stroke and three months after stroke.The results will be analyzed with
      SPSS (IBM SPSS Statistics 17, Chicago, IL, USA). Repeated measures analysis of variance
      (repeated ANOVA) and the Chi-square test for categorical variables will be used for comparing
      the outcome data. If there are significant interactions, a post hoc test with Bonferroni
      correction will be used to examine group differences within a time condition. A p value <
      0.05 will be considered statistically significant.
    

Intervention name(s): early mobilization; early standard intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): early out-of-bed activities including supine to sit training, sit on the edge of bed without supporting, standing with hand supporting, stepping while standing etc.within three days after stroke while being monitored by medical equipment.; Conventional early in-bed activities within three days after stroke
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early mobilization; Acute stroke; Early intervention; Early mobilization therapy