Very Early Rehabilitation in Acute Ischemic Stroke

NCT ID: NCT01694992

Last Updated: 2012-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Keywords

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Stroke Early Ambulation Rehabilitation Physical Therapy Randomized controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Early mobilization

Intervention Type OTHER

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).

Control

The Control Group will follow within the routines of the hospital as is usually done.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type OTHER

Other Intervention Names

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Early Physiotherapy Program

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sheila CO Martins, Physician

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre (Hospital)

Locations

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Hospital de Clínicas de Porto Alegre (Hospital)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Simone RP Gobbato, Physiotherapist

Role: CONTACT

Phone: 55 51 9982 3387

Email: [email protected]

Sheila CO Martins, Physician

Role: CONTACT

Phone: 55 51 9962 8467

Email: [email protected]

Facility Contacts

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Simone RP Gobbato, Physiotherapist

Role: primary

Sheila CO Martins, Physician

Role: backup

References

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Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.

Reference Type DERIVED
PMID: 34695300 (View on PubMed)

Other Identifiers

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11.0121

Identifier Type: -

Identifier Source: org_study_id