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

• Sponsor: Shengjing Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02718534
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 44
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Time of First Rehabilitation Therapy	Behavioral: stroke rehabilitation	N/A

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

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effectiveness and Safeness of Early Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset: a Randomized Controlled Trial
• Actual Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Aug 1, 2017
• Actual Study Completion Date: Nov 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The primary outcome was a favourable outcome at 3 months after stroke, measured with the Fugl-Meyer motor function score. [90 days]

   Fugl-Meyer score

Secondary Outcome Measures

1. The primary outcome was a favourable outcome at 3 months after stroke, measured with Modified Rankin Scale score. [90 days]

   Modified Rankin Scale score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: 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:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shengjing hospital of China Medical University	Shenyang	Liaoning	China	110004

Sponsors and Collaborators

• Shengjing Hospital

Investigators

• Principal Investigator: Hongyu Zhao, doctor, Shengjing Hospital

Study Documents (Full-Text)

None provided.

More Information

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

• Responsible Party: Hongyu Zhao, deputy director of emergency department, Shengjing Hospital
• ClinicalTrials.gov Identifier: NCT02718534
• Other Study ID Numbers: ERTAS; LNCCC-D12-2015
• First Posted: Mar 24, 2016
• Last Update Posted: Jan 5, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Jan 5, 2021