A Very Early Rehabilitation Trial

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

Interventions

OTHER

Standard Care + VEM

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

OTHER

Standard care

Sponsors & Collaborators

• Singhealth Foundation

  collaborator OTHER_GOV

• Chest, Heart and Stroke Association Scotland

  collaborator OTHER

• Northern Ireland Chest Heart and Stroke

  collaborator OTHER

• The Stroke Association - UK

  collaborator UNKNOWN

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Neuroscience Trials Australia

  lead OTHER

Principal Investigators

• Julie Bernhardt, PhD · The Florey Institute of Neuroscience and Mental Health

• Leonid Churilov, PhD · The Florey Institute of Neuroscience and Mental Health

• Helen Dewey, MD · Monash University

• Richard Lindley Dewey, MD · George Institute for Global Health

• Janice Collier, PhD · The Florey Institute of Neuroscience and Mental Health

• Amanda Thrift, PhD · Monash University

• Geoffrey Donnan, MD · The Florey Institute of Neuroscience and Mental Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-06-30

Primary Completion

2014-12-31

Completion

2015-01-31

Countries

• Australia

Study Locations