The Effectiveness of Early Mobilization for Acute Ischemic Stroke Treated With Rt-PA or IA Thrombectomy

NCT ID: NCT03680469

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-05
• Study Completion Date: 2022-06-10

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard early rehabilitation

The standard early rehabilitation program after acute stroke is an intervention regularly utilized in the stroke center of National Taiwan University Hospital.

Group Type: ACTIVE_COMPARATOR

standard early rehabilitation

Intervention Type: BEHAVIORAL

The standard early rehabilitation program is an intervention regularly utilized in the stroke center of National Taiwan University Hospital. Activities performed in the standard early rehabilitation program within 24-72 hours of onset include(1) bed exercises including the joint range of motion exercise, bridge exercise, the straight leg raising exercise, stretching exercises, and facilitation techniques, and (2) functional training in which the patients are instructed to engage in the repetitive and systematic practice of tasks, such as rolling or sitting supported on the bed.

adding early out-of-bed mobilization

The adding early out-of-bed mobilization treatment will be defined as the patients with acute ischemic stroke who receive out-of-bed mobilization treatment in addition to standard early rehabilitation care.

Group Type: EXPERIMENTAL

standard early rehabilitation

Intervention Type: BEHAVIORAL

The standard early rehabilitation program is an intervention regularly utilized in the stroke center of National Taiwan University Hospital. Activities performed in the standard early rehabilitation program within 24-72 hours of onset include(1) bed exercises including the joint range of motion exercise, bridge exercise, the straight leg raising exercise, stretching exercises, and facilitation techniques, and (2) functional training in which the patients are instructed to engage in the repetitive and systematic practice of tasks, such as rolling or sitting supported on the bed.

adding early out-of-bed mobilization

Intervention Type: BEHAVIORAL

Early mobilization treatment involving out-of-bed, task-specific activities including rolling and sitting up, sitting unsupported out of bed, and standing within 24-72 hours of onset and accounting for more than two thirds of the treatment time in early rehabilitation .

Interventions

standard early rehabilitation

The standard early rehabilitation program is an intervention regularly utilized in the stroke center of National Taiwan University Hospital. Activities performed in the standard early rehabilitation program within 24-72 hours of onset include(1) bed exercises including the joint range of motion exercise, bridge exercise, the straight leg raising exercise, stretching exercises, and facilitation techniques, and (2) functional training in which the patients are instructed to engage in the repetitive and systematic practice of tasks, such as rolling or sitting supported on the bed.

Intervention Type: BEHAVIORAL

adding early out-of-bed mobilization

Early mobilization treatment involving out-of-bed, task-specific activities including rolling and sitting up, sitting unsupported out of bed, and standing within 24-72 hours of onset and accounting for more than two thirds of the treatment time in early rehabilitation .

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiann-Shing Jeng, PhD

Role: PRINCIPAL_INVESTIGATOR

Stroke Center & Department of Neurology, National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201807045RINB

Identifier Type: -

Identifier Source: org_study_id