Visit | Screening | Instruction (Videotherapy and Non-Video Group) | Baseline | Training phase | End of Training | Follow-up |
---|---|---|---|---|---|---|
Time | Week 1: Day 1-3 | Week 1: Day 4-5 | Week 2 | Week 2 – 7 + 4 days | Week 8 + 4 days | Week 31 + 1 week |
Screening, supervision | ||||||
Informed consent | X | Â | Â | Â | Â | Â |
Inclusion/exclusion criteria | X | Â | Â | Â | Â | Â |
Background medical history | X | Â | Â | Â | Â | Â |
Concomitant medication | X | Â | Â | Â | Â | Â |
Screening | X | Â | Â | Â | Â | Â |
Beck Depression Inventory | X | Â | X | X (week 5) | X | X |
Amount of training with videotherapy DVDs | Â | Â | Â | Â | Â | X |
Preparation of patient | ||||||
Instruction and training | Â | X | Â | Â | Â | Â |
Primary efficacy endpoint | ||||||
Wolf Motor Function Test | Â | Â | X | Â | X | X |
Secondary efficacy endpoint | ||||||
Frenchay Arm Test | Â | Â | X | Â | X | X |
Stroke Impact Scale | Â | Â | X | Â | X | X |
Barthel-Index | X | Â | X | X (week 5) | X | X |
Modified Rankin Scale | X | Â | X | Â | X | X |
Motor Activity Log | Â | Â | X | X (week 5) | X | X |
Box and Block Test | Â | Â | X | Â | X | X |
Further treatment | ||||||
Telephone calls | Â | Â | Â | Weekly | Â | Â |
Diary | Â | Â | Â | Daily by the patient | Â | Â |