Early Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset(ERTAS) (ERTAS)

January 3, 2021 updated by: Hongyu Zhao, Shengjing Hospital

Effectiveness and Safeness of Early Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset: a Randomized Controlled Trial

This study aimed to evaluate effectiveness of initial limb rehabilitation compare therapy took place within 48h with therapy took place after 48h for patients with stroke (modified Rankin Scale Score 3-4).

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Early rehabilitation after stroke is thought to contribute to the effects of stroke-unit care. However, time of initial rehabilitation therapy is poorly defined and not underpinned by strong evidence in patients with stroke (modified Rankin Scale Score 3-4). The investigators do this parallel-group, single-blind, randomized controlled trial in shengjing hospital of China Medical University. Participants (aged≥18 years) with ischaemic or haemorrhagic stroke, first or recurrent, who meet physiological criteria are randomly assigned (1:1), to receive usual stroke therapy. Treatment with recombinant tissue plasminogen activator is allowed. Randomisation is stratified by study site and stroke severity. The primary outcome was a outcome 3 months after stroke, defined as a modified Rankin Scale score of 3-4. The investigators do analysis on an intention-to-treat basis.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • 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

    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital of China Medical University

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients were diagnosed acute stroke within 24h onset. Head CT or MRI scans were confirmed the diagnosed.
  2. The age was from 18 to 75 years old.
  3. Temperature ≤38.0℃,Pulse rate 60-100bpm,Respiratory rate≤24 bpm,systolic blood pressure≤220mmHg.
  4. Glasgow score: 9-14.
  5. Acute Physiology and Chronic Health Evaluation(APACHE Ⅱ)score: ≤17.
  6. National Institutes of Health Stroke Scale (NIHSS)score: <16. (Upper and lower extremity motor function item score<8).
  7. Modified Rankin Scale score:3-4.
  8. There were no serious diseases before, such as heart, liver, kidney and lung diseases.
  9. Patients themselves or their nominated representative sign the informed consent form.

Exclusion Criteria:

  1. There were unstable vital sign. There were serious organic dysfunction (heart, liver, kidney or lung).
  2. Patients with transient ischemic attack.
  3. Patients with subarachnoid haemorrhage.
  4. Patients with haemorrhage were documented immediate surgery.
  5. Pregnancy patients with stroke.
  6. During the course of the project, major diseases took place (such as, myocardial infarction, gastrointestinal bleeding, respiratory failure, pulmonary embolism, deep vein thrombosis).

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERTAS-1
first limb rehabilitation therapy took place within 48h for patients with acute stroke (modified Rankin Scale Score 3-4)
Physical rehabilitation exercise between 24 and 48 hours and after 48 hours
Active Comparator: ERTAS-2
first limb rehabilitation therapy took place after 48h for patients with acute stroke (modified Rankin Scale Score 3-4)
Physical rehabilitation exercise between 24 and 48 hours and after 48 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome was a favourable outcome at 3 months after stroke, measured with the Fugl-Meyer motor function score.
Time Frame: 90 days
Fugl-Meyer score
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome was a favourable outcome at 3 months after stroke, measured with Modified Rankin Scale score.
Time Frame: 90 days
Modified Rankin Scale score
90 days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Hongyu Zhao, doctor, Shengjing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

March 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (Estimate)

March 24, 2016

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

January 3, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • ERTAS
  • LNCCC-D12-2015 (Other Grant/Funding Number: Health and family planning commission of Liaoning Province. China.)

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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