Very Early Rehabilitation in Acute Ischemic Stroke

Stroke Clinical Trial

— VERIS-Brazil  

Official title:

Randomized Clinical Trial of Very Early Rehabilitation Compared With Conventional Rehabilitation in Acute Ischemic Stroke in the Vascular Unit of the Hospital de Clínicas de Porto Alegre - HCPA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01694992
• Other study ID #: 11.0121
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: September 25, 2012
• Last updated: September 25, 2012
• Start date: March 2012
• Est. completion date: August 2015

Study information

• Verified date: September 2012
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Simone RP Gobbato, Physiotherapist
• Phone: 55 51 9982 3387
• Email: sissipoletto[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: Associação Fundo de Incentivo à PesquisaBrazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of a rehabilitation (physiotherapy) program in patients with acute ischemic stroke in Acute Vascular Unit and in general ward of Hospital de Clínicas de Porto Alegre, and to verify the degree of disability at fourteenth and third month, functional improvement at third month, the frequency of deaths and incidence of complications due to immobility and quantify the time spent in hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: August 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with clinical diagnosis of acute ischemic stroke (first or recurrent) confirmed by CCT or MRI admitted to the Acute Vascular Unit of HCPA between the first 48 hours of onset of symptoms.

• Patients older than 18 years.

• Patients clinically and hemodynamically stable (SBP 120-220 mmHg, SatO2 up to 92% with or without supplementation, HR between 60 and 100 bmp, body temperature below 38 and RR below 25 bpm).

• Patients are able to react to verbal commands even without being fully alert (Glasgow Scale above 8).

• Prior Rankin until 3

• Motor deficit and / or coordination measured by the NIHSS

Exclusion Criteria:

• Patients with clinical and / or hemodynamic instability

• Patients with hemorrhagic stroke or TIA (transient ischemic attack).

• Patients with progressive neurological disease and acute coronary disease and / or unstable.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Early mobilization
The Intervention Group - Early Mobilization - will follow the early physiotherapy program within the first 24 - 48 hours after acute ischemic stroke, five times per week for 30 minutes plus time to spent out of bed (sitting).

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre (Hospital)	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability	Outcome measure are assessed by Modified Rankin Scale. Good outcome was predefined as an mRS score of 0 to 2 and poor outcome of 3 to 6.	three months	No
Secondary	Minimum or no Disability	Measured by the modified Ranking Scale with score of 0 to 1.	three months	No
Secondary	Independence in activities of daily living	Measured by the modified Barthel Index, where score < 75 indicate dependence and score > 75 is independence.	three months	No
Secondary	Long of stay at hospital	Number of days in hospital	three month	No
Secondary	Death	Determined by a blinded review of the clinical details by the investigators.	three month	Yes
Secondary	Incidence of complications	Number of complications (pneumonia and deep vein thrombosis) at three month	three month	No