Time Window for Early Mobilization After Acute Ischemic Stroke

Overview

Early mobilization was thought to be effective in patients with acute ischemic stroke. As the essential component of stroke unit care, early mobilization has already been part of routine clinical practice. However, it is uncertain that which and when medical service focusing on functional recovery should be delivered after the emergency interventions for stroke. Besides, the optimal time window, for delivering early mobilization after acute ischemic stroke, has not been verified with strong evidence.

Full Title of Study: “Time Window for Early Mobilization in Improving Prognostic Outcomes in Patients With Acute Ischemic Stroke: a Pragmatic, Multi-center, Randomized Controlled, Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 2022

Detailed Description

Objective: The primary objective of the TwEmAIS trial is to investigate the optimal time window for delivering early mobilization in improving the neurologic impairment and functional recovery in patients with acute ischemic stroke. Secondary objectives are to evaluate the efficacy of early mobilization on disability level after stroke, activity of daily living (ADL), cognitive ability, hospital LOS and cost-effectiveness.

Study design: a pragmatic, investigator-initiated, multi-center, randomized controlled, clinical trial.

Sample size: 1500 cases

According to the function evaluation of each patient, the corresponding rehabilitation treatment was arranged.

Statistical analysis: Statistical analysis was performed with SPSS 23.0. One-way analysis of variance was used to compare statistical differences between the groups (5 time points) and between groups (3 intervention groups).

Interventions

  • Other: early rehabilitation
    • The three study groups share a same intervention protocol in addition to the initiation timing of intervention from the stroke onset. The frequency and intensity of the intervention is titrated according to functional activity baseline and monitored daily and adjusted with recovery. Encourage patients to move out of bed as soon as possible. Definition of bed movement: Encourage and help patients to perform functional actions, focusing on activities such as sitting, standing, walking out of the bed.

Arms, Groups and Cohorts

  • Experimental: very early rehabilitation
    • early mobilization initiates within 24h from the onset of the disease
  • Experimental: relative early rehabilitation
    • early mobilization initiates between 24-72h from the onset of the disease
  • Experimental: early rehabilitation
    • early mobilization initiates after 72h from the onset of the disease

Clinical Trial Outcome Measures

Primary Measures

  • NIHSS scores
    • Time Frame: the total score of NIHSS will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally
    • National Institute of Health stroke scale,total scores range from 0 to 42, higher values represent a better outcome.

Secondary Measures

  • Barthel Index
    • Time Frame: the total score of Barthel Index will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally
    • ability of daily living, total scores range from 0 to 100, higher values represent a better outcome and independent living ability.
  • modified Rankin Scale
    • Time Frame: the degree of modified Rankin Scale will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally
    • modified Rankin Scale, to evaluate a subject’s disability status. It’s a rating data. The degrees range from 0 to 6, higher values represent a worse outcome and severe disability.
  • MMSE
    • Time Frame: the total score of MMSE will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally
    • Mini-mental State Examination. To evaluate a subject’s mental state.The total score range from 0 to 30, higher values represent a better outcome.
  • NIHSS scores
    • Time Frame: the total score of NIHSS will be recorded15days、1month、6months after the cerebrovascular accident/or the last time appeared normally
    • National Institute of Health stroke scale,total scores range from 0 to 42, higher values represent a better outcome.
  • Incidence of important medical events
    • Time Frame: The incidence of important medical events will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally
    • falls, trauma, fracture, syncope, epilepsy, pneumonia, atelectasis, venous thrombosis, pulmonary embolism, pressure sores, death, etc.
  • Hospital LOS
    • Time Frame: Hospital LOS will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally
    • length of stay in the acute hospital and in the rehabilitation hospital, and total hospital length of stay
  • Total medical cost
    • Time Frame: medical cost will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally
    • addition of the cost of each admission of the acute hospital and the rehabilitation hospital

Participating in This Clinical Trial

Inclusion Criteria

  • 1 age > 18 years;
  • 2 diagnosed with ischemic stroke through medical history, clinical symptoms and radiographic assessment;
  • 3 onset of ischemic stroke within 24h;
  • 4 able to response to the instructions orally;
  • 5 with stable vital signs (systolic blood pressure of 120-180mmHg, heart rate of 50-100/min, body temperature < 38.5 °C, blood oxygen saturation > 92%);
  • 6MMSE score > 16;
  • 7the participation in the TwEmAIS trial and sign the consent form.

Exclusion Criteria

  • 1 diagnosed with hemorrhagic stroke;
  • 2 NIHSS score < 2;
  • 3 patients with continuous progressing disease within the first hour after admission, presence of progressive neurological damage, acute coronary syndrome, severe heart failure, confirmed or suspected lower extremity fracture;
  • 4 pre-stroke MRS score of 3-5 due to various medical conditions;
  • 5 refuse the randomization;
  • 6 with severe limb dysfunction or systemic diseases and being unable to cooperate with the rehab training;
  • 7 with severe cognitive and mental dysfunctions;
  • 8 participated in other trials previously.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • China Stroke Databank Center
  • Collaborator
    • The First Affiliated Hospital with Nanjing Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lu Xiao, MD/PHD, Principal Investigator, The First Affiliated Hospital with Nanjing Medical University
  • Overall Contact(s)
    • Lu Xiao, MD/PHD, +86 025-83718836, luxiao1972@163.com

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