Table 2 Outcome measures, assessments, and frequency and scope of study visits
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 | |||||
Inclusion/exclusion criteria | X | |||||
Background medical history | X | |||||
Concomitant medication | X | |||||
Screening | X | |||||
Beck Depression Inventory | X | X | X (week 5) | X | X | |
Amount of training with videotherapy DVDs | X | |||||
Preparation of patient | ||||||
Instruction and training | X | |||||
Primary efficacy endpoint | ||||||
Wolf Motor Function Test | X | X | X | |||
Secondary efficacy endpoint | ||||||
Frenchay Arm Test | X | X | X | |||
Stroke Impact Scale | X | X | X | |||
Barthel-Index | X | X | X (week 5) | X | X | |
Modified Rankin Scale | X | X | X | X | ||
Motor Activity Log | X | X (week 5) | X | X | ||
Box and Block Test | X | X | X | |||
Further treatment | ||||||
Telephone calls | Weekly | |||||
Diary | Daily by the patient | |||||