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

NCT03680469 | Completed

• 1 other identifier: 201807045RINB
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

Ischemic Stroke; Acute; Early intervention; Mobilization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  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

  within 2 weeks after stroke

Other Outcomes (2)

• Safety/Adverse event outcome

  up to 4 weeks after stroke

• the length of stay in the stroke center

  within admission

Study Arms (2)

standard early rehabilitation

ACTIVE COMPARATOR

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

adding early out-of-bed mobilization

EXPERIMENTAL

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; Behavioral: adding early out-of-bed mobilization

Interventions

standard early rehabilitation 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; standard early rehabilitation

adding early out-of-bed mobilization 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 .

adding early out-of-bed mobilization

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ℃

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jiann-Shing Jeng, PhD

  Stroke Center & Department of Neurology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 21, 2018
• Study Start: October 5, 2018
• Primary Completion: October 10, 2018
• Study Completion: June 10, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)