AVERT-DOSE version 2
Research type
Research Study
Full title
A Phase 3, Multi arm, Multi stage, Covariate-Adjusted, Response-Adaptive Randomised Trial to Determine Optimal Early Mobility Training after Stroke Short title -Determining Optimal Early Mobility Training after Stroke (AVERT DOSE)
IRAS ID
270352
Contact name
Thompson Robinson
Contact email
Sponsor organisation
The Florey Institute of Neuroscience and Mental Health
Clinicaltrials.gov Identifier
U1111-1221-2442, UTN; ACTRN12619000557134, ANZCTR
Duration of Study in the UK
years, months, days
Research summary
AVERT DOSE involves participants who have had a stroke, and subsequently have difficulty with mobility activities such as sitting, standing and walking. The main aim of the research project is to test different mobility intervention regimens in the acute phase after stroke to determine which provides the most benefit. Eligible/consenting participants complete a series of baseline assessments to determine the effect of stroke. Medical history, and demographics are collected as well as routine hospital care information. Participants are randomly assigned to one of four different mobility training groups. The study uses a covariate adjusted, response adaptive design which means the arms of therapy that are least beneficial, are reduced and removed during the study at a pre-defined time point. Physiotherapists/nurses provide training sessions to the participant within 48hrs of stroke onset, until discharge from hospital, or 14 days post randomisation. Sessions are designed to aid in the recovery of mobility. Follow-up visits occur at 3 months and 6 months after the stroke by a blinded assessor who visits the participant at their place of residence or follow up clinic. Visits last approximately 90 minutes and include a series of outcome assessments.
REC name
London - Bromley Research Ethics Committee
REC reference
19/LO/1517
Date of REC Opinion
10 Dec 2019
REC opinion
Further Information Favourable Opinion