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

November 27, 2022 updated by: National Taiwan University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at baseline, at 2 weeks after stroke, at 4 weeks after stroke, and at follow-up 3 months after stroke

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The total score-change of the Postural Assessment Scale for Stroke Patients (PASS) assessment for postural stability
Time Frame: at baseline, at 2 weeks after stroke, at 4 weeks after stroke, and at follow-up 3 months after stroke
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
Time Frame: within 2 weeks after stroke
the achievement of the three motor milestones (yes or no/ days)
within 2 weeks after stroke

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety/Adverse event outcome
Time Frame: up to 4 weeks after stroke
Number of participants with serious adverse event
up to 4 weeks after stroke
the length of stay in the stroke center
Time Frame: within admission
the length of stay in the stroke center
within admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jiann-Shing Jeng, PhD, Stroke Center & Department of Neurology, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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