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

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.

Citation

Bhakta, B., Hartley, S., Holloway, I., Couzens, A., Ford, G., Meads, D., Sackley, C. M., Walker, M. F., Ruddock, S., & 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

• Journal Article Type: Article
• Acceptance Date: Jul 21, 2014
• Publication Date: Aug 8, 2014
• Deposit Date: Oct 21, 2016
• Publicly Available Date: Oct 21, 2016
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 15
• Issue: 316
• DOI: https://doi.org/10.1186/1745-6215-15-316
• Keywords: Stroke, study protocol, randomized controlled trial, occupational therapy, physical therapy
• Public URL: https://nottingham-repository.worktribe.com/output/734359
• Publisher URL: http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-15-316
• Related Public URLs: https://creativecommons.org/licenses/by/4.0/
• Contract Date: Oct 21, 2016