Stroke Center, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 122
- Locations
- 2
- Primary Endpoint
- The total score-change of the Functional Independence Measure (FIM) assessment for daily living function
Study Overview
Brief Summary
The purpose of the study will to test the hypothesis that combining early out-of-bed mobilization within 72 hours of stroke onset with treated by intravenous recombinant tissue-type plasminogen activator (IV-rtPA) or endovascular thrombectomy (ET) would result in a greater benefit than standard early rehabilitation within 72 hours of stroke onset with treated by IV-rtPA or ET.
Detailed Description
The treatments for acute ischemic stroke have evolved rapidly in recent years including intravenous (IV) thrombolysis using recombinant tissue-type plasminogen activator (rtPA) and endovascular thrombectomy (ET). Those new interventions constitute a landmark change in stroke treatment. Since early mobilizing patients after stroke as early as possible might prevent immobility-related complications and promote brain recovery, previous studies supported that early mobilization should commence at some point within 72 hours of stroke. However, increased risk of symptomatic intracerebral hemorrhage or ischemia-reperfusion injury underlies concerns early mobilization of patients treated with rtPA or ET. Bedside, a limited amount of research has investigated what specific timing for starting early mobilization after intravenous IV rtPA or ET would optimize recovery potential during the acute period after cerebral infarction. Further research is needed to understand whether the outcomes resulting from starting mobilization within 72 hours of onset for a stroke treated with rtPA or ET is better than that of starting mobilization later. Therefore, the purpose of the study will to test the hypothesis that combining early out-of-bed mobilization within 72 hours of stroke onset with treated by IV rtPA or ET would result in a greater benefit than standard early rehabilitation within 72 hours of stroke onset with treated by IV rtPA or ET.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •for experimental group: first ischemic stroke episode to receive either medical therapy (including intravenous thrombolysis using recombinant tissue-type plasminogen activator within 3 hours of onset) or endovascular therapy within 8 hours of onset (including intravenous thrombolysis following thrombectomy); for control group: first ischemic stroke episode to receive general medical therapy;
- •completely activities of daily living independent before stroke;
- •age above 20 years old;
- •stroke with unilateral hemiparesis lesions confirmed using magnetic resonance imaging or computed tomography;
- •no other peripheral or central nervous system dysfunction;
- •no active inflammation or pathologic changes in the joints;
- •no other active medical problems; and
- •able to react to verbal commands, with systolic blood pressure between 120 and 160 mm Hg when resting, oxygen saturation >92% (with or without supplementation), and a heart rate below 130 beats per minute when resting with temperature <38.5 ℃
Exclusion Criteria
- •unstable vital sign;
- •medical conditions unrelated to the cerebrovascular accident but which have affected walking performance;
- •any other cognitive, emotional, or behavioral impairments resulting in insufficient comprehension, understanding, or collaboration;
- •unable receive the informed consent form
- •acute deterioration within 24 hours or symptomatic intracerebral hemorrhage defined by a parenchymal hemorrhage type 2 within 36 hours with an increase of 4 points or more in National Institute of Health Stroke Scale;
- •acute hydrocephalus within 24 hours of onset
Outcomes
Primary Outcomes
The total score-change of the Functional Independence Measure (FIM) assessment for daily living function
Time Frame: at baseline, at 2 weeks after stroke, at 4 weeks after stroke, and at follow-up 3 months after stroke
The total FIM with total score ranges from 13 to 126, which was used to assess each patient's capacities in terms of activities of daily living, comprises 18 seven-level items and assesses dependence in self-care, sphincter management, transfer, locomotion, communication, social interaction, and cognition. The functional independence of patient's capacities in terms of activity of daily living. Higher values represent a better outcome and all subscales are summed as a total score.
Secondary Outcomes
- Achievement of the walking motor milestones(within 2 weeks after stroke)
- The total score-change of the Postural Assessment Scale for Stroke Patients (PASS) assessment for postural stability(at baseline, at 2 weeks after stroke, at 4 weeks after stroke, and at follow-up 3 months after stroke)