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Very Early Rehabilitation in Acute Ischemic Stroke

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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01694992
Acronym
VERIS-Brazil
Enrollment
184
Registered
2012-09-27
Start date
2012-03-31
Completion date
2015-08-31
Last updated
2012-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Early Ambulation, Rehabilitation, Physical Therapy, Randomized controlled trial

Brief 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.

Interventions

OTHEREarly 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).

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Disabilitythree monthsOutcome 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.

Secondary

MeasureTime frameDescription
Minimum or no Disabilitythree monthsMeasured by the modified Ranking Scale with score of 0 to 1.
Independence in activities of daily livingthree monthsMeasured by the modified Barthel Index, where score \< 75 indicate dependence and score \> 75 is independence.
Long of stay at hospitalthree monthNumber of days in hospital
Deaththree monthDetermined by a blinded review of the clinical details by the investigators.
Incidence of complicationsthree monthNumber of complications (pneumonia and deep vein thrombosis) at three month

Countries

Brazil

Contacts

Primary ContactSimone RP Gobbato, Physiotherapist
sissipoletto@hotmail.com55 51 9982 3387
Backup ContactSheila CO Martins, Physician
scmartins@hcpa.ufrgs.br55 51 9962 8467

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026