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

Not Applicable

Completed

• Conditions: Time of First Rehabilitation Therapy
• Interventions: Behavioral: stroke rehabilitation

• Registration Number: NCT02718534
• Lead Sponsor: Shengjing Hospital

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-18
• Study First Posted: 2016-03-24
• Primary Completion: 2017-08
• Study Completion: 2019-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-03
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERTAS-1	stroke rehabilitation	first limb rehabilitation therapy took place within 48h for patients with acute stroke (modified Rankin Scale Score 3-4)
ERTAS-2	stroke rehabilitation	first limb rehabilitation therapy took place after 48h for patients with acute stroke (modified Rankin Scale Score 3-4)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The primary outcome was a favourable outcome at 3 months after stroke, measured with Modified Rankin Scale score.	90 days	Modified Rankin Scale score

Trial Locations

Locations (1)

Shengjing hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China