Abstract
BackgroundStroke 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/designDopamine 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.DiscussionThe 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 registrationISRCTN99643613 assigned on 4 December 2009.
Highlights
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)
Rehabilitation remains the cornerstone treatment within the NHS and the current consensus suggests early rehabilitation interventions are likely to be of greater benefit
Enhancing the effect of conventional physical rehabilitation with L-dopa is likely to have greater impact when linked to early stroke care through a stroke unit and through community rehabilitation services
Summary
Stroke has a huge impact, leaving more than a third of survivors with lasting disability. The nature of the optimal packaging and ensuring maximum pharmacoadherance was designed in collaboration with input from clinicians, pharmacy staff, people with stroke and their families and the manufacturer of IMP This includes design and implementation of appropriate training for those dispensing the trial intervention both in the hospital and when patients are selfmedicating at home. A key aspect of the design of the DARS trial is the recognition of the varied configuration of community stroke rehabilitation services as well as a system for continuity of provision of trial intervention after discharge from hospital given that the length of stay in hospitals for people with acute stroke is decreasing.
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