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- Title
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.
- Authors
Bhakta, Bipin B; Hartley, Suzanne; Holloway, Ivana; Couzens, J Alastair; Ford, Gary A; Meads, David; Sackley, Catherine M; Walker, Marion F; Ruddock, Sharon P; Farrin, Amanda J
- Abstract
<bold>Background: </bold>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.<bold>Methods/design: </bold>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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>ISRCTN99643613 assigned on 4 December 2009.
- Publication
Trials, 2014, Vol 15, Issue 1, p316
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/1745-6215-15-316