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Open Access Study protocol

The DARS (Dopamine Augmented Rehabilitation in Stroke) trial: protocol for a randomised controlled trial of Co-careldopa treatment in addition to routine NHS occupational and physical therapy after stroke

Bipin B Bhakta1, Suzanne Hartley1*, Ivana Holloway1, J Alastair Couzens2, Gary A Ford34, David Meads1, Catherine M Sackley5, Marion F Walker6, Sharon P Ruddock1 and Amanda J Farrin1

Author Affiliations

1 University of Leeds, Leeds, UK

2 NHS Grampian, Aberdeen, UK

3 Oxford University Hospitals NHS Trust, Oxford, UK

4 University of Oxford, Oxford, UK

5 University of East Anglia, Norwich, Norfolk, UK

6 University of Nottingham, Nottingham, UK

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Trials 2014, 15:316  doi:10.1186/1745-6215-15-316

Published: 8 August 2014

Abstract

Background

Stroke has a huge impact, leaving more than a third of affected people with lasting disability and rehabilitation remains a cornerstone treatment in the National Health Service (NHS). Recovery of mobility and arm function post-stroke occurs through re-learning to use the affected body parts and/or learning to compensate with the lesser affected side. Promising evidence suggests that the addition of Co-careldopa to physical therapy and occupational therapy may improve the recovery of arm and leg movement and lead to improved function.

Methods/design

Dopamine Augmented Rehabilitation in Stroke (DARS) is a multi-centre double-blind, randomised, placebo, controlled clinical trial of Co-careldopa in addition to routine NHS occupational therapy and physical therapy as part of early stroke rehabilitation. Participants will be randomised on a 1:1 basis to either Co-careldopa or placebo. The primary objective of the trial is to determine whether the addition of six weeks of Co-careldopa treatment to rehabilitation therapy can improve the proportion of patients who can walk independently eight weeks post-randomisation.

Discussion

The DARS trial will provide evidence as to whether Co-careldopa, in addition to routine NHS occupational and physical therapy, leads to a greater recovery of motor function, a reduction in carer dependency and advance rehabilitation treatments for people with stroke.

Trial registration

ISRCTN99643613 assigned on 4 December 2009.

Keywords:
Stroke; Rehabilitation; L-dopa; Mobility; Recovery; Double-blind; Placebo; Trial