Back to resultsEarly Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset(ERTAS) (ERTAS)
Primary Purpose
Time of First Rehabilitation Therapy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
stroke rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Time of First Rehabilitation Therapy
Eligibility Criteria
Inclusion Criteria:
- Patients were diagnosed acute stroke within 24h onset. Head CT or MRI scans were confirmed the diagnosed.
- The age was from 18 to 75 years old.
- Temperature ≤38.0℃，Pulse rate 60-100bpm，Respiratory rate≤24 bpm，systolic blood pressure≤220mmHg.
- Glasgow score: 9-14.
- Acute Physiology and Chronic Health Evaluation(APACHE Ⅱ)score: ≤17.
- National Institutes of Health Stroke Scale (NIHSS)score: <16. (Upper and lower extremity motor function item score<8).
- Modified Rankin Scale score:3-4.
- There were no serious diseases before, such as heart, liver, kidney and lung diseases.
- Patients themselves or their nominated representative sign the informed consent form.
Exclusion Criteria:
- There were unstable vital sign. There were serious organic dysfunction (heart, liver, kidney or lung).
- Patients with transient ischemic attack.
- Patients with subarachnoid haemorrhage.
- Patients with haemorrhage were documented immediate surgery.
- Pregnancy patients with stroke.
- During the course of the project, major diseases took place (such as, myocardial infarction, gastrointestinal bleeding, respiratory failure, pulmonary embolism, deep vein thrombosis).
Sites / Locations
- Shengjing hospital of China Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ERTAS-1
ERTAS-2
Arm Description
first limb rehabilitation therapy took place within 48h for patients with acute stroke (modified Rankin Scale Score 3-4)
first limb rehabilitation therapy took place after 48h for patients with acute stroke (modified Rankin Scale Score 3-4)
Outcomes
Primary Outcome Measures
The primary outcome was a favourable outcome at 3 months after stroke, measured with the Fugl-Meyer motor function score.
Fugl-Meyer score
Secondary Outcome Measures
The primary outcome was a favourable outcome at 3 months after stroke, measured with Modified Rankin Scale score.
Modified Rankin Scale score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02718534
Brief Title
Early Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset(ERTAS)
Acronym
ERTAS
Official Title
Effectiveness and Safeness of Early Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
November 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Time of First Rehabilitation Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ERTAS-1
Arm Type
Experimental
Arm Description
first limb rehabilitation therapy took place within 48h for patients with acute stroke (modified Rankin Scale Score 3-4)
Arm Title
ERTAS-2
Arm Type
Active Comparator
Arm Description
first limb rehabilitation therapy took place after 48h for patients with acute stroke (modified Rankin Scale Score 3-4)
Intervention Type
Behavioral
Intervention Name(s)
stroke rehabilitation
Intervention Description
Physical rehabilitation exercise between 24 and 48 hours and after 48 hours
Primary Outcome Measure Information:
Title
The primary outcome was a favourable outcome at 3 months after stroke, measured with the Fugl-Meyer motor function score.
Description
Fugl-Meyer score
Time Frame
90 days
Secondary Outcome Measure Information:
Title
The primary outcome was a favourable outcome at 3 months after stroke, measured with Modified Rankin Scale score.
Description
Modified Rankin Scale score
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients were diagnosed acute stroke within 24h onset. Head CT or MRI scans were confirmed the diagnosed.
The age was from 18 to 75 years old.
Temperature ≤38.0℃，Pulse rate 60-100bpm，Respiratory rate≤24 bpm，systolic blood pressure≤220mmHg.
Glasgow score: 9-14.
Acute Physiology and Chronic Health Evaluation(APACHE Ⅱ)score: ≤17.
National Institutes of Health Stroke Scale (NIHSS)score: <16. (Upper and lower extremity motor function item score<8).
Modified Rankin Scale score:3-4.
There were no serious diseases before, such as heart, liver, kidney and lung diseases.
Patients themselves or their nominated representative sign the informed consent form.
Exclusion Criteria:
There were unstable vital sign. There were serious organic dysfunction (heart, liver, kidney or lung).
Patients with transient ischemic attack.
Patients with subarachnoid haemorrhage.
Patients with haemorrhage were documented immediate surgery.
Pregnancy patients with stroke.
During the course of the project, major diseases took place (such as, myocardial infarction, gastrointestinal bleeding, respiratory failure, pulmonary embolism, deep vein thrombosis).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongyu Zhao, doctor
Organizational Affiliation
Shengjing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shengjing hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
25892679
Citation
AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet. 2015 Jul 4;386(9988):46-55. doi: 10.1016/S0140-6736(15)60690-0. Epub 2015 Apr 16. Erratum In: Lancet. 2015 Jul 4;386(9988):30. Lancet. 2017 May 13;389(10082):1884.
Results Reference
background
PubMed Identifier
33736542
Citation
Wang F, Zhang S, Zhou F, Zhao M, Zhao H. Early physical rehabilitation therapy between 24 and 48 h following acute ischemic stroke onset: a randomized controlled trial. Disabil Rehabil. 2022 Jul;44(15):3967-3972. doi: 10.1080/09638288.2021.1897168. Epub 2021 Mar 18.
Results Reference
derived
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Early Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset(ERTAS)
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