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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

Bhakta, BB; Hartley, S; Holloway, I; Couzens, A; Ford, GA; Meads, D; Sackley, Catherine Mary; Walker, Marion F.; Ruddock, SP; Farrin, AJ

Authors

BB Bhakta

S Hartley

I Holloway

A Couzens

GA Ford

D Meads

Catherine Mary Sackley

Marion F. Walker

SP Ruddock

AJ Farrin



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.

Journal Article Type Article
Publication Date Aug 8, 2014
Journal Trials
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 15
Issue 316
APA6 Citation Bhakta, B., Hartley, S., Holloway, I., Couzens, A., Ford, G., Meads, D., …Farrin, A. (2014). 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. Trials, 15(316), https://doi.org/10.1186/1745-6215-15-316
DOI https://doi.org/10.1186/1745-6215-15-316
Keywords Stroke, study protocol, randomized controlled trial, occupational therapy, physical therapy
Publisher URL http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-15-316
Related Public URLs https://creativecommons.org/licenses/by/4.0/
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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