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

Stroke Center, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Behavioral: standard early rehabilitation; Behavioral: adding early out-of-bed mobilization

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 Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Behavioral: 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.
EXPERIMENTAL: 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.	Behavioral: 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.; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total score-change of the Functional Independence Measure (FIM) assessment for daily living function	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.	at baseline, at 2 weeks after stroke, at 4 weeks after stroke, and at follow-up 3 months after stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total score-change of the Postural Assessment Scale for Stroke Patients (PASS) assessment for postural stability	The Postural Assessment Scale for Stroke Patients (PASS): The PASS contains 12 four-level items of varying difficulty for assessing a patient's ability to maintain or change a given lying, sitting, or standing posture. Its total score ranges from 0 to 36.Higher values represent a better outcome and all subscales are summed as a total score.	at baseline, at 2 weeks after stroke, at 4 weeks after stroke, and at follow-up 3 months after stroke
Achievement of the walking motor milestones	the achievement of the three motor milestones (yes or no/ days)	within 2 weeks after stroke

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety/Adverse event outcome	Number of participants with serious adverse event	up to 4 weeks after stroke
the length of stay in the stroke center	the length of stay in the stroke center	within admission

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Jiann-Shing Jeng, PhD, Stroke Center & Department of Neurology, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 5, 2018
• Primary Completion (ACTUAL): October 10, 2018
• Study Completion (ACTUAL): June 10, 2022

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (ACTUAL): September 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 27, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Ischemic Stroke; Early intervention; Mobilization; Acute
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: 201807045RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No