NCT01694992

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P75+ for phase_1 stroke

Timeline
Completed

Started Mar 2012

Typical duration for phase_1 stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

Enrollment Period

9 months

First QC Date

September 25, 2012

Last Update Submit

September 25, 2012

Conditions

Stroke

Keywords

StrokeEarly AmbulationRehabilitationPhysical TherapyRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Minimum or no Disability

    three months

  • Independence in activities of daily living

    three months

  • Long of stay at hospital

    three month

  • Death

    three month

  • Incidence of complications

    three month

Study Arms (2)

Early mobilization

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Early mobilizationOTHER

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).

Also known as: Early Physiotherapy Program
Early mobilization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre (Hospital)

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34695300DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Sheila CO Martins, Physician

    Hospital de Clínicas de Porto Alegre (Hospital)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone RP Gobbato, Physiotherapist

CONTACT

55 51 9982 3387sissipoletto@hotmail.com

Sheila CO Martins, Physician

CONTACT

55 51 9962 8467scmartins@hcpa.ufrgs.br

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2012

First Posted

September 27, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2012

Study Completion

August 1, 2015

Last Updated

September 27, 2012

Record last verified: 2012-09

Locations

BR(1)