Arm Intervention After Stroke (AIAS): a feasibility study

INTERVENTION: The participants will be randomly allocated to one of the three following arms: 1. Standard care: usual therapy, provided by physiotherapists and occupational therapists 2. ArmeoSpring arm orthosis intervention 1: 40 minutes, 3 times a week, in addition to standard care 3. ArmeoSpring arm orthosis intervention 2: 60 minutes, 5 times a week, in addition to standard care Total duration of interventions: 2 weeks or discharge (whichever is sooner) Total duration of follow‐up: 3 months ArmeoSpring intervention will be delievered by a research therapist. CONDITION: Acute stroke ; Circulatory System ; Stroke, not specified as haemorrhage or infarction PRIMARY OUTCOME: 1. Feasibility of experimental interventions: ; 1.1. Number of per protocol interventions recorded at end of intervention period; 1.2. Reasons for non‐compliance recorded at end of intervention period; 2. Acceptability/satisfaction of experimental intervention: informal interviews with participants completed at the end of the intervention period SECONDARY OUTCOME: Safety outcomes: ; 1. Arm pain (including shoulder) (measured by 5 point scale none‐excruciating); 2. Shoulder subluxation (clinical report); 3. Fatigue (Borg perceived Exertion Scale); 4. All adverse events; Safety outcomes will be continously monitored and recorded throughout the study, however will be formally recorded at the end of the intervention period (2 weeks or discharge) (by clinical report and patient scales) and at 3 month report (by patient report and scales, on appropriate measures).; ; Efficacy outcomes:; 1. Upper limb function: Action Research Arm Test; 2. Upper limb impairment: Fugl‐Meyer assessment (upper limb section); 3. Disability: Barthel Index; ; Exploratory outcome: ; To assist in power calculation to determine the number of subjects required for a phase III randomised controlled trial. INCLUSION CRITERIA: 1. Age greater than 18 years, either sex 2. Clinical diagnosis of stroke 3. Minimum grade 1 on MRC scale for arm impairment 4. Maximum grade 4 on MRC scale for arm impairment 5. Medically stable 6. Informed consent 7. Ability to understand and follow simple instructions 8. Sitting balance sufficent to use Armeo arm orthosis safely