Very Early Rehabilitation in Acute Ischemic Stroke (VERIS-Brazil)
This study is currently recruiting participants.
Verified September 2012 by Hospital de Clinicas de Porto Alegre
Sponsor:
Hospital de Clinicas de Porto Alegre
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01694992
First received: September 25, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Other: Early mobilization |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Hospital de Clinicas de Porto Alegre:
Primary Outcome Measures:
- Disability [ Time Frame: three months ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Minimum or no Disability [ Time Frame: three months ] [ Designated as safety issue: No ]Measured by the modified Ranking Scale with score of 0 to 1.
- Independence in activities of daily living [ Time Frame: three months ] [ Designated as safety issue: No ]Measured by the modified Barthel Index, where score < 75 indicate dependence and score > 75 is independence.
- Long of stay at hospital [ Time Frame: three month ] [ Designated as safety issue: No ]Number of days in hospital
- Death [ Time Frame: three month ] [ Designated as safety issue: Yes ]Determined by a blinded review of the clinical details by the investigators.
- Incidence of complications [ Time Frame: three month ] [ Designated as safety issue: No ]Number of complications (pneumonia and deep vein thrombosis) at three month
| Estimated Enrollment: | 184 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Early mobilization
The Intervention Group - Early Mobilization - will follow the early physiotherapy program within the first 24 - 48 hours after stroke, five times per week for 30 plus a time spent out of bed (sitting).
|
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).
Other Name: Early Physiotherapy Program
|
|
No Intervention: Control
The Control Group will follow within the routines of the hospital as is usually done.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694992
Contacts
| Contact: Simone RP Gobbato, Physiotherapist | 55 51 9982 3387 | sissipoletto@hotmail.com |
| Contact: Sheila CO Martins, Physician | 55 51 9962 8467 | scmartins@hcpa.ufrgs.br |
Locations
| Brazil | |
| Hospital de Clínicas de Porto Alegre (Hospital) | Recruiting |
| Porto Alegre, Rio Grande do Sul, Brazil, 90035-903 | |
| Contact: Simone RP Gobbato, Physiotherapist 55 51 9982 3387 sissipoletto@hotmail.com | |
| Contact: Sheila CO Martins, Physician 55 51 9962 8467 scmartins@hcpa.ufrgs.br | |
| Sub-Investigator: Simone RP Gobbato, Physiotherapist | |
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
| Principal Investigator: | Sheila CO Martins, Physician | Hospital de Clínicas de Porto Alegre (Hospital) |
More Information
No publications provided
| Responsible Party: | Hospital de Clinicas de Porto Alegre |
| ClinicalTrials.gov Identifier: | NCT01694992 History of Changes |
| Other Study ID Numbers: | 11.0121 |
| Study First Received: | September 25, 2012 |
| Last Updated: | September 25, 2012 |
| Health Authority: | Brazil: Associação Fundo de Incentivo à Pesquisa Brazil: Ethics Committee Brazil: National Committee of Ethics in Research |
Keywords provided by Hospital de Clinicas de Porto Alegre:
|
Stroke Early Ambulation Rehabilitation Physical Therapy Randomized controlled trial |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 22, 2013