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A Very Early Rehabilitation Trial (AVERT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Stroke Research Institute, Australia
Sponsor:
Collaborators:
Singhealth Foundation
Chest, Heart and Stroke Association Scotland
Northern Ireland Chest Heart and Stroke
The Stroke Association - UK
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
National Stroke Research Institute, Australia
ClinicalTrials.gov Identifier:
NCT01846247
First received: April 30, 2013
Last updated: October 16, 2014
Last verified: September 2014
  Purpose

Phase 3, multicenter, international randomized controlled trial of a Very Early Mobilization(VEM) care rehabilitation protocol compared to standard post stroke care (SC). Participants receive either SC and VEM or SC alone in the acute phase of stroke up to a period of 14 days.

Participants are followed up by a blinded assessor at 3 and 12 months post stroke to determine trial outcomes.


Condition Intervention
Stroke
Other: Standard Care + VEM
Other: Standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicentre, Randomised Controlled Trial of Very Early Rehabilitation After Stroke.

Resource links provided by NLM:


Further study details as provided by National Stroke Research Institute, Australia:

Primary Outcome Measures:
  • modified Rankin Score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Favorable outcome (0-2) modified Rankin Score


Secondary Outcome Measures:
  • Safety. Death rate and severity of important medical events [ Time Frame: up until 3 months ] [ Designated as safety issue: Yes ]
    Important medical events (stroke progression, recurrent stroke, falls, angina, myocardial infarction, deep vein thrombosis, pulmonary emboli, pressure sores, chest infections, urinary tract infections, depression) at 3 months.

  • Time to unassisted walking over 50 meters and the proportion achieving unassisted walking [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Achieves walking independently or with supervision over 50 meters

  • modified Rankin Score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Assumption free ordinal approach

  • Health related Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    AQoL

  • Cost effectiveness and cost utility [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    comprehensive questionaire


Estimated Enrollment: 2014
Study Start Date: June 2006
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Standard Care
Standard stroke unit rehabilitation care
Other: Standard care
Experimental: Standard Care + VEM
Standard stroke unit rehabilitation care in addition to a very early rehabilitation protocol
Other: Standard Care + VEM
Patient will receive standard stroke unit care with earlier and additional physiotherapy and nursing sessions as per an intervention protocol.

Detailed Description:

People who suffer a stroke are often left with disabilities such as weakness, or problems with speech, thinking, or control or bodily functions. Severe strokes often result in death. The results of a recent European study indicated that patients who commence mobility training very early after a stroke (Day 1) recover the ability to walk more quickly and return home sooner and in greater numbers than those who start training one week or later after stroke. Recently a phase II (pilot) AVERT study was conducted in which the investigators tested the safety and feasibility of very early mobilisation (European model) Stroke patients in this study randomly received either standard care or very early mobilisation (VEM). The study showed that there was no harm to patients in the VEM group compared to those who had standard care and that delivering VEM was feasible. Consequently, a grant to conduct the larger phase III study, to test the effectiveness of the intervention was obtained.

In this next phase III trial, the investigators aim to look at 2104 patients across stroke care units in city and regional hospitals. Each hospital will be asked to include between 30 and 60 patients per year to the study. All stroke patients admitted to the hospital Stroke Unit or ward at the hospital will be invited to participate. Medical clearance will be obtained for all potential participants. Those unconscious or too ill, together with those already participating in acute drug trials will be excluded. Patients who are able will provide their own consent to participate. Those who are not able to consent for themselves will have a third party (usually a relative) acknowledge their participation in the study. As this is a blinded controlled trial, keeping the assessor and patients unaware of their treatment group is important. The investigators will inform patients that they will have a 50% chance of receiving one of two rehabilitation types during their hospitalization if they decide to participate. Patients in the VEM group will commence treatment within 24 hours of admission to hospital. VEM will be provided by a trained AVERT physiotherapist, and AVERT study nurse and aims to improve functional mobility. The mobilization activities will depend on the patient's functional ability and tolerance to exercise. Patients will be closely monitored prior to mobilization and will only be mobilised if they meet requirements for blood pressure and other vital signs. The number of sessions and the time spent for each patient will vary, however specific targets are to be met according to the intervention protocol. The content and timing of all treatment received by participants in either group will be recorded. The treatment period for this study is from the time of the patients consent, until day 14 or discharge from the stroke unit or ward. (Whichever is earlier). All participants will be assessed at admission to the study, 3 months, and 12 months after their stroke. Information collected by the AVERT physiotherapists and nurses and the assessor will be recorded on individual case record forms and on a secure web based data base. Therapists also add some information to a palm pilot, and then download it onto the secure website. All information collected from patients will be treated as confidential in line with international guidelines and local law.

The primary outcome measure for the study is the number of patients dead and disabled at 3 months after stroke. Other secondary outcome measures include the safety of patients, quality of life, and cost effectiveness. An independent Data Monitoring committee will monitor the safety, conduct and efficacy of the trial. In addition, an independent outcomes committee will be reviewing all events that are reported as serious.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • Clinical diagnosis of first or recurrent stroke, hemorrhage or infarct.
  • Recruited within 24 hours of onset of stroke symptoms
  • Admission in a stroke care unit
  • Consciousness: At a minimum patient must at least react to verbal commands.

Exclusion Criteria:

  • pre stroke mRS of 3,4 or 5
  • Deterioration in patients condition resulting in direct admission to ICU, decision to palliate or surgery.
  • Concurrent diagnosis of rapidly deteriorating disease
  • Unstable coronary or other medical condition that is judged by the investigator to impose a hazard to the patient by involvement
  • Patients unable to be mobilized within 24 hours of onset. (eg bed rest policy post tPA, lower limb fracture)
  • Other interventional trials
  • Systolic BP less than 110 or greater than 220mmHg
  • Oxygen saturation of less than 92 % with supplementation
  • Resting heart rate of less than 40 or greater than 110 beats per minute
  • Temperature of greater than 38.5 degrees C
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01846247

Contacts
Contact: Julie Bernhardt, PhD 613 9035 7072 j.bernhardt@unimelb.edu.au
Contact: Fiona Ellery, BA 613 9035 7072 fellery@unimelb.edu.au

Locations
Australia, Victoria
Florey Institute for Neuroscience and Mental health Recruiting
Melbourne, Victoria, Australia, 3084
Contact: Julie Bernhardt, PhD    61 3 9035 7072    j.bernhardt@unimelb.edu.au   
Contact: Fiona Ellery, BA (App Sci - Nursing)    61 3 9035 7042    fellery@unimelb.edu.au   
Principal Investigator: Hannah Williamson, BA         
Sponsors and Collaborators
National Stroke Research Institute, Australia
Singhealth Foundation
Chest, Heart and Stroke Association Scotland
Northern Ireland Chest Heart and Stroke
The Stroke Association - UK
National Institute for Health Research, United Kingdom
Investigators
Study Director: Julie Bernhardt, PhD The Florey Institute of Neuroscience and Mental Health
Principal Investigator: Leonid Churilov, PhD The Florey Institute of Neuroscience and Mental Health
Principal Investigator: Helen Dewey, MD Monash University
Principal Investigator: Richard Lindley Dewey, MD George Institute for Global Health
Principal Investigator: Janice Collier, PhD The Florey Institute of Neuroscience and Mental Health
Principal Investigator: Amanda Thrift, PhD Monash University
Principal Investigator: Geoffrey Donnan, MD The Florey Institute of Neuroscience and Mental Health
  More Information

No publications provided

Responsible Party: National Stroke Research Institute, Australia
ClinicalTrials.gov Identifier: NCT01846247     History of Changes
Other Study ID Numbers: version3 25April08, ACTRN12606000185561
Study First Received: April 30, 2013
Last Updated: October 16, 2014
Health Authority: Australia: Human Research Ethics Committee
Singapore: Institutional Review Board
New Zealand: Institutional Review Board
United Kingdom: National Health Service

Keywords provided by National Stroke Research Institute, Australia:
stroke

Additional relevant MeSH terms:
Stroke
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014