Early Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset(ERTAS)
This trial is active, not recruiting.
|Condition||limb rehabilitation after stroke is studied.|
|Phase||phase 1/phase 2|
|Start date||March 2016|
|End date||May 2017|
|Trial size||100 participants|
|Trial identifier||NCT02718534, ERTAS, LNCCC-D12-2015|
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).
first limb rehabilitation therapy took place within 48h for patients with acute stroke (modified Rankin Scale Score 3-4)
first limb rehabilitation therapy took place after 48h for patients with acute stroke (modified Rankin Scale Score 3-4)
The primary outcome was a favourable outcome at 3 months after stroke, measured with the Fugl-Meyer motor function score.
time frame: 90 days
Male or female participants from 18 years up to 75 years old.
- Patients were diagnosed acute stroke within 24h onset. Head CT or MRI scans were confirmed the diagnosed.
- The age was from 18 to 75 years old.
- Temperature ≤38.0℃，Pulse rate 60-100bpm，Respiratory rate≤24 bpm，systolic blood pressure≤220mmHg.
- Glasgow score: 9-14.
- Acute Physiology and Chronic Health Evaluation(APACHE Ⅱ)score: ≤17.
- National Institutes of Health Stroke Scale (NIHSS)score: ＜16. (Upper and lower extremity motor function item score＜8).
- Modified Rankin Scale score:3-4.
- There were no serious diseases before, such as heart, liver, kidney and lung diseases.
- Patients themselves or their nominated representative sign the informed consent form.
- There were unstable vital sign. There were serious organic dysfunction (heart, liver, kidney or lung).
- Patients with transient ischemic attack.
- Patients with subarachnoid haemorrhage.
- Patients with haemorrhage were documented immediate surgery.
- Pregnancy patients with stroke.
- During the course of the project, major diseases took place (such as, myocardial infarction, gastrointestinal bleeding, respiratory failure, pulmonary embolism, deep vein thrombosis).
|Official title||Effectiveness and Safeness of Early Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset: a Randomized Controlled Trial|
|Principal investigator||Hongyu Zhao, doctor|
|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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