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

Table 1 Schedule of events

Assessment		Timeline (months post randomisation)
Assessment	Baseline	8 weeks (+/- 7 days)	6 months (+/- 14 days)	12 months (+/- 14 days)
Eligibility and consent	X
Baseline data (researcher/nurse completed from routinely collected data and ward staff)
Rivermead Mobility Index (professional perspective on patient’s ability for stratification)	X
Past medical history	X
Lesion location and type (CT scan)	X
Montreal Cognitive Assessment (MoCA)	X
Randomisation (within 42 days post stroke)	X
Patient questionnaires (completed via researcher interview with patient)
Rivermead Mobility Index (patient’s perspective on ability)	X	X	X	X
ABILHAND scale	X¹	X	X	X
Nottingham Extended Activities of Daily Living Scale	X¹	X	X	X
General Health Questionnaire 12	X	X	X	X
EQ-5D	X	X	X	X
Barthel Index (postal version but collected face to face)	X	X	X	X
MSK-SSP Manikin	X¹	X	X	X
Fatigue Assessment Scale		X	X	X
Health Economics Resource Use Questionnaire	X	X	X	X
Carer questionnaires (Carer completed)
Caregiver Burden Scale		X	X	X
EQ-5D	X	X	X	X
Health Economics Resource Use Questionnaire	X¹	X	X	X
Qualitative follow-up
Patient/therapist perspective regarding use of IMP		X
Clinical follow-up data (researcher/therapist/nurse completed)
Treatment data (rehabilitation and drug compliance)		X
Modified Rankin Scale		X	X
Montreal Cognitive Assessment (MOCA)		X	X	X
Serious and non-serious adverse event monitoring	Continuous reporting as occur
New significant medical/surgical illness (e.g. for stroke, myocardial infarction, cancer, fracture, elective surgical procedures)			X	X

ISSN: 1745-6215