NCT02718534

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Shengjing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Time of First Rehabilitation Therapy

Interventions

Type	Name	Description
BEHAVIORAL	stroke rehabilitation	Physical rehabilitation exercise between 24 and 48 hours and after 48 hours

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-08-01
• Completion: 2019-11-01
• First posted: 2016-03-24
• Last updated: 2021-01-05

Locations

1 site across 1 country: China