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

Primary Purpose

Acute Ischemic Stroke

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

standard early rehabilitation

adding early out-of-bed mobilization

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Ischemic Stroke, Acute, Early intervention, Mobilization

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard early rehabilitation

adding early out-of-bed mobilization

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Achievement of the walking motor milestones

the achievement of the three motor milestones (yes or no/ days)

Full Information

NCT ID

NCT03680469

First Posted

September 20, 2018

Last Updated

November 27, 2022

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03680469

Brief Title

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

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

October 5, 2018 (Actual)

Primary Completion Date

October 10, 2018 (Actual)

Study Completion Date

June 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke

Keywords

Ischemic Stroke, Acute, Early intervention, Mobilization

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

standard early rehabilitation

Arm Type

Active Comparator

Arm Description

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

Arm Title

adding early out-of-bed mobilization

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

standard early rehabilitation

Intervention Description

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

Intervention Name(s)

adding early out-of-bed mobilization

Intervention Description

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 .

Primary Outcome Measure Information:

Title

The total score-change of the Functional Independence Measure (FIM) assessment for daily living function

Description

Time Frame

at baseline, at 2 weeks after stroke, at 4 weeks after stroke, and at follow-up 3 months after stroke

Secondary Outcome Measure Information:

Title

The total score-change of the Postural Assessment Scale for Stroke Patients (PASS) assessment for postural stability

Description

Time Frame

at baseline, at 2 weeks after stroke, at 4 weeks after stroke, and at follow-up 3 months after stroke

Title

Achievement of the walking motor milestones

Description

the achievement of the three motor milestones (yes or no/ days)

Time Frame

within 2 weeks after stroke

Other Pre-specified Outcome Measures:

Title

Safety/Adverse event outcome

Description

Number of participants with serious adverse event

Time Frame

up to 4 weeks after stroke

Title

the length of stay in the stroke center

Description

the length of stay in the stroke center

Time Frame

within admission

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiann-Shing Jeng, PhD

Organizational Affiliation

Stroke Center & Department of Neurology, National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

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

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