Table 2 Study procedure and assessment
Study procedure | Screening and baseline assessment | Control group, standard care | Intervention group, 0–3 months daily sessions of 24 min or more | Post-treatment assessment | |||
|---|---|---|---|---|---|---|---|
Inpatients | Outpatients | 3 months | 6 months | 12 months | |||
Informed consent | x | x | |||||
Medical history | Patients’ demographics MRI/CT scan when available | ||||||
Assessment: domains and scales | |||||||
Disability and impairment | Barthel Index (BI) | x | x | x | |||
Stroke Impact Scale (SIS) | x | x | |||||
Fugl-Meyer Assessment of the upper limb (UE-FM) | x | x | x | ||||
Chedoke Arm and Hand Activity Inventory (CAHAI) | x | x | |||||
Hamilton Depression Rating Scale (HDRS) | x | x | |||||
Visual analog score (VAS) for pain | x | xa | |||||
Modified Ashworth Scale (AS) for spasticity | xa | x | |||||
Fatigue Severity Scale (FSS) | x | x | |||||
Grip forcea | xa | xa | |||||
Kinematics from the motion capture camera of the RGS@home system | x | x | x | ||||
RGSwear data (paretic arm) | Continuous | ||||||
Incidents related to use | x | x | |||||
Number and reason of dropouts | x | x | |||||
Acceptability and usability Questionnaire for patients and physicians. | x | x | x | ||||
Quality of life | Stroke Specific Quality of Life scale (SSSQOL) | x | x | ||||
Number of falls | x | x | x | ||||
Short-Form-36 (SF-36) | x | x | x | ||||