DARS - Dopamine Augmented Rehabilitation in Stroke V1.0

• Research type

  Research Study

• Full title

  Does Co-careldopa treatment in combination with routine NHS occupational and physical therapy, delivered early after stroke within a stroke service, improve functional recovery including walking and arm function?

• IRAS ID

  38769

• Contact name

  Bipinchandra Bhakta

• Sponsor organisation

  University of Leeds

• Eudract number

  2009-017925-20

• ISRCTN Number

  99643613

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Stroke is the commonest cause of severe disability (in the UK annual incidence of first stroke is 100,000), with the number of disabled stroke survivors increasing due to aging population demographics. Stroke has a huge impact, leaving over a third of affected people with lasting disability affecting self care. One year after stroke, 31% are still dependent for outside mobility and 15% for inside mobility. Although acute stroke interventions can reduce mortality and morbidity, it is widely acknowledged that rehabilitation remains the cornerstone treatment. For stroke sufferers, learning is an essential process by which recovery of mobility and arm function occurs, either through re-learning to use the affected body parts and/or learning to compensate with the lesser affected side. There is promising evidence which indicates that combining certain drugs with physical and occupational therapy may improve the recovery of arm and leg movements essential to day to day activities such as walking. The purpose of this study is to find out if combining L-dopa (using co-careldopa; a widely available inexpensive drug commonly used to treat Parkinson's disease) with routine occupational and physical therapy enhances the effect of this therapy and whether it further improves recovery of functionally useful arm and leg movement in people with first ever stroke. People with stroke will be randomly allocated to receive either active drug (co-careldopa) or a placebo tablet. Participants will receive their allocated treatment approximately 45-60 minutes before routine occupational or physical therapy sessions, up to a maximum of twice per day over a 6week period. All participants will receive the usual stroke care within both hospital and post-discharge settings. Participants will be assessed by an independent researcher using pre-determined outcome measures at baseline, 8weeks, 6months and 12months after study entry. Where applicable, caregiver consent will also be sought to allow assessment of carer burden.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  10/H1005/6

• Date of REC Opinion

  11 Feb 2010

• REC opinion

  Further Information Favourable Opinion