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

Time of First Rehabilitation Therapy Clinical Trial

— ERTAS  

Official title:

Effectiveness and Safeness of Early Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02718534
• Other study ID #: ERTAS
• Secondary ID: LNCCC-D12-2015
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: November 2019

Study information

• Verified date: January 2021
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2019
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ?)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).

Related Conditions & MeSH terms

• Stroke
• Time of First Rehabilitation Therapy

Intervention

Behavioral:
• stroke rehabilitation
Physical rehabilitation exercise between 24 and 48 hours and after 48 hours

Locations

Country	Name	City	State
China	Shengjing hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. Erratum in: Lancet. 2017 May 13;389(10082):1884. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome was a favourable outcome at 3 months after stroke, measured with the Fugl-Meyer motor function score.	Fugl-Meyer score	90 days
Secondary	The primary outcome was a favourable outcome at 3 months after stroke, measured with Modified Rankin Scale score.	Modified Rankin Scale score	90 days