A Very Early Rehabilitation Trial

NCT01846247 | Completed DMC

• 2 other identifiers: version3 25April08ACTRN12606000185561
• Study Type: interventional
• Target: 2,014
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

stroke

Outcome Measures

Primary Outcomes (1)

• modified Rankin Score

  Favorable outcome (0-2) modified Rankin Score

  3 months

Secondary Outcomes (5)

• Safety. Death rate and severity of important medical events

  up until 3 months

• Time to unassisted walking over 50 meters and the proportion achieving unassisted walking

  3 Months

• modified Rankin Score

  3 months

• Health related Quality of life

  12 months

• Cost effectiveness and cost utility

  12 months

Study Arms (2)

Standard Care

PLACEBO COMPARATOR

Standard stroke unit rehabilitation care

Other: Standard care

Standard Care + VEM

EXPERIMENTAL

Standard stroke unit rehabilitation care in addition to a very early rehabilitation protocol

Other: Standard Care + VEM

Interventions

Standard Care + VEM OTHER

Patient will receive standard stroke unit care with earlier and additional physiotherapy and nursing sessions as per an intervention protocol.

Standard Care + VEM

Standard care OTHER

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuroscience Trials Australia: lead
• Singhealth Foundation: collaborator
• Chest, Heart and Stroke Association Scotland: collaborator
• Northern Ireland Chest Heart and Stroke: collaborator
• The Stroke Association - UK: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Florey Institute for Neuroscience and Mental health

Melbourne, Victoria, 3084, Australia

Location

Related Publications (3)

• Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.

  PMID: 34184251 DERIVED

• Sheppard L, Dewey H, Bernhardt J, Collier JM, Ellery F, Churilov L, Tay-Teo K, Wu O, Moodie M; AVERT Trial Collaboration Group. Economic Evaluation Plan (EEP) for A Very Early Rehabilitation Trial (AVERT): An international trial to compare the costs and cost-effectiveness of commencing out of bed standing and walking training (very early mobilization) within 24 h of stroke onset with usual stroke unit care. Int J Stroke. 2016 Jun;11(4):492-4. doi: 10.1177/1747493016632254. Epub 2016 Mar 2.

  PMID: 26936861 DERIVED

• Bernhardt J, Raffelt A, Churilov L, Lindley RI, Speare S, Ancliffe J, Katijjahbe MA, Hameed S, Lennon S, McRae A, Tan D, Quiney J, Williamson HC, Collier J, Dewey HM, Donnan GA, Langhorne P, Thrift AG; AVERT Trialists' Collaboration. Exploring threats to generalisability in a large international rehabilitation trial (AVERT). BMJ Open. 2015 Aug 17;5(8):e008378. doi: 10.1136/bmjopen-2015-008378.

  PMID: 26283667 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Julie Bernhardt, PhD

  The Florey Institute of Neuroscience and Mental Health

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 3, 2013
• Study Start: June 1, 2006
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

AU (1)