Table 2.
Part 1 | Part 2 | Part 3 | |||
---|---|---|---|---|---|
Enrollment | Visit 1 | Visit 2 | Visit 3 | Visit 4a) | |
Timeline | Diagnosis of stroke | During hospital stay | Before rehabilitation | End of intervention | Follow-up |
Admission | |||||
Day 0 + 3 days | Day 3 + 3 | Day 7 ± 3 | Day 28 ± 3 | 3 months ± 7 days | |
Check for inclusion/exclusion criteria | X | ||||
Randomization | X | ||||
Informed consentb | X | ||||
Baseline data | X | ||||
Neurological assessment | X | X | X | X | |
Edinburgh Handedness Inventory (EHI) | X | ||||
(p)mRS | X | X | X | X | |
NIHSS | X | X | X | X | X |
BI | X | X | X | X | |
LAST | X | X | X | X | X |
ACL | X | X | X | X | X |
BIAS | X | X | X | X | X |
BDI | X | X | X | X | |
(EQ-5D-5L) | X | X | X | X | |
Evaluation of self-training (h/day) | X | X | X | X |
Alternative: phone call if personal consultation is not possible.
If not able to get permission from the patients themselves, their legal guardian will have to give written informed consent for their contribution.
ACL, Aphasia Check List; BDI, Beck Depression Inventory; BIAS, Bielefelder Aphasie Screening; BI, Barthel Index; CNS, central nervous system; mRS, modified Rankin-Scale; NIHSS, National Institutes of Health Stroke Scale; LAST, Language Screening Test.