Time of First Rehabilitation TherapyERTASNCT02718534
Early Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset(ERTAS)
A study testing stroke rehabilitation in people with Time of First Rehabilitation Therapy, run by Shengjing Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Time of First Rehabilitation Therapy
- What is being tested?
- stroke rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Shengjing hospital of China Medical University
Shenyang, Liaoning, 110004
About this study
Official title: 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).
Read the 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.
- Conditions
- Time of First Rehabilitation Therapy
- Being tested
- stroke rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stroke rehabilitationBehavioural
Physical rehabilitation exercise between 24 and 48 hours and after 48 hours
| Study group | Role | What they receive |
|---|---|---|
| ERTAS-1 | Experimental | first limb rehabilitation therapy took place within 48h for patients with acute stroke (modified Rankin Scale Score 3-4) Receives: Behavioral: stroke rehabilitation |
| ERTAS-2 | Active comparator | first limb rehabilitation therapy took place after 48h for patients with acute stroke (modified Rankin Scale Score 3-4) Receives: Behavioral: stroke rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was a favourable outcome at 3 months after stroke, measured with the Fugl-Meyer motor function score.
Fugl-Meyer score
Measured: 90 days
Secondary outcomes (1)
The primary outcome was a favourable outcome at 3 months after stroke, measured with Modified Rankin Scale score.
Modified Rankin Scale score
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2017
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Time of First Rehabilitation TherapyStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongyu Zhao, Shengjing Hospital
- Investigators
- Hongyu Zhao, doctor, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718534
- Sponsor's protocol ID
- ERTAS
- Other IDs
- LNCCC-D12-2015
- Acronym
- ERTAS
- Status last verified
- Jan 2021
- First submitted
- 15 Mar 2016
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 25892679Wang 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.
PubMed 33736542
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safeness of Early Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02718534
- Acronym / sponsor ID
- ERTAS / ERTAS
- Conditions
- Time of First Rehabilitation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERTAS-1 | Experimental | Behavioral: stroke rehabilitationfirst limb rehabilitation therapy took place within 48h for patients with acute stroke (modified Rankin Scale Score 3-4) |
| ERTAS-2 | Active comparator | Behavioral: stroke rehabilitationfirst limb rehabilitation therapy took place after 48h for patients with acute stroke (modified Rankin Scale Score 3-4) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stroke rehabilitationPhysical rehabilitation exercise between 24 and 48 hours and after 48 hours | Behavioural | ERTAS-1, ERTAS-2 |
Primary outcome
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
1 secondary outcome
The primary outcome was a favourable outcome at 3 months after stroke, measured with Modified Rankin Scale score.
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Background: PubMed 25892679AVERT 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.
- Derived from this study: PubMed 33736542Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongyu Zhao, doctor principal investigator
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stroke rehabilitation in people with Time of First Rehabilitation Therapy, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was a favourable outcome at 3 months after stroke, measured with the Fugl-Meyer motor function score. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02718534, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.