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CompletedNCT02718534ERTASUpdated Jan 5, 2021

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

An interventional study of stroke rehabilitation in Time of First Rehabilitation Therapy, sponsored by Shengjing Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-01-05.

Sponsored by Shengjing Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Time of First Rehabilitation Therapy

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03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 120 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Shengjing Hospital is the lead sponsor of 124 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    ERTAS-1

    first limb rehabilitation therapy took place within 48h for patients with acute stroke (modified Rankin Scale Score 3-4)

    Behavioral: stroke rehabilitation

  • Active comparator
    ERTAS-2

    first limb rehabilitation therapy took place after 48h for patients with acute stroke (modified Rankin Scale Score 3-4)

    Behavioral: stroke rehabilitation

Interventions

  • Behavioralstroke rehabilitation

    Physical rehabilitation exercise between 24 and 48 hours and after 48 hours

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What researchers measure

Primary outcomes

  1. The primary outcome was a favourable outcome at 3 months after stroke, measured with the Fugl-Meyer motor function score.

    Fugl-Meyer score

    Time frame: 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

    Time frame: 90 days

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Study locations

1 site
  • Shengjing hospital of China Medical University
    Shenyang, Liaoning 110004, China
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References and documents

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. doi: 10.1016/S0140-6736(15)61204-1. Lancet. 2017 May 13;389(10082):1884. doi: 10.1016/S0140-6736(17)31213-8. PubMed 25892679 ↗
  • 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. PubMed 33736542 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02718534
Lead sponsor
Shengjing Hospital
Responsible party
Hongyu Zhao (deputy director of emergency department, Shengjing Hospital) — Principal investigator
First posted
Mar 24, 2016
Start date
Mar 2016
Primary completion
Aug 2017
Completion
Nov 2019
Last update
Jan 5, 2021

Study contacts

Hongyu Zhao, doctor
principal investigator · Shengjing Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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