Clinical trial NCT02718534: Early Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset(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
Overall status: COMPLETED
Phase: NA
Conditions: Time of First Rehabilitation Therapy
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The primary outcome was a favourable outcome at 3 months after stroke, measured with the Fugl-Meyer motor function score.
timeFrame: 90 days
Secondary outcomes:
measure: The primary outcome was a favourable outcome at 3 months after stroke, measured with Modified Rankin Scale score.
timeFrame: 90 days
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Hongyu Zhao, doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.