- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02718534
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
Conditions
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:
- 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).
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.
Sponsor
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.
General Publications
- 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.
- 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.
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
Additional Relevant MeSH Terms
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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