Assessment | Â | Timeline (months post randomisation) | ||
---|---|---|---|---|
Baseline | 8 weeks (+/- 7 days) | 6 months (+/- 14 days) | 12 months (+/- 14 days) | |
Eligibility and consent | X | Â | Â | Â |
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 |