Clinical trial NCT03680469: The Effectiveness of Early Mobilization for Acute Ischemic Stroke Treated With Rt-PA or IA Thrombectomy
Official title: Stroke Center, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Ischemic Stroke
Acute
Early intervention
Mobilization
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 122
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. completely activities of daily living independent before stroke;
3. age above 20 years old;
4. stroke with unilateral hemiparesis lesions confirmed using magnetic resonance imaging or computed tomography;
5. no other peripheral or central nervous system dysfunction;
6. no active inflammation or pathologic changes in the joints;
7. no other active medical problems; and
8. 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:

1. unstable vital sign;
2. medical conditions unrelated to the cerebrovascular accident but which have affected walking performance;
3. any other cognitive, emotional, or behavioral impairments resulting in insufficient comprehension, understanding, or collaboration;
4. unable receive the informed consent form
5. 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;
6. acute hydrocephalus within 24 hours of onset

Primary outcomes:
measure: The total score-change of the Functional Independence Measure (FIM) assessment for daily living function
timeFrame: at baseline, at 2 weeks after stroke, at 4 weeks after stroke, and at follow-up 3 months after stroke
Secondary outcomes:
measure: The total score-change of the Postural Assessment Scale for Stroke Patients (PASS) assessment for postural stability
timeFrame: at baseline, at 2 weeks after stroke, at 4 weeks after stroke, and at follow-up 3 months after stroke
measure: Achievement of the walking motor milestones
timeFrame: within 2 weeks after stroke
Other outcomes:
measure: Safety/Adverse event outcome
timeFrame: up to 4 weeks after stroke
measure: the length of stay in the stroke center
timeFrame: within admission
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Stroke Center & Department of Neurology, National Taiwan University Hospital
name: Jiann-Shing Jeng, PhD
role: PRINCIPAL_INVESTIGATOR
References: