Table 2.
Overview of the outcome measures at different time points in the study
| Study week | Screening | Baseline | 1–11 wks | 12 wks | 13–23 wks | 24 wks |
|---|---|---|---|---|---|---|
| Informed consent | ● | |||||
| Inclusion/exclusion criteria | ● | |||||
| Demographics | ● | |||||
| Concomitant disorders | ● | |||||
| Medical history | ● | |||||
| Medication | ● | |||||
| Adverse events/vital signs | ● | ● | ● | ● | ● | |
| Assessment | ||||||
| Blood and urine test | ● | ● | ||||
| Height/weight | ● | ● | ● | |||
| GMFCS | ● | ● | ● | |||
| GMFM-88 | ● | ● | ● | |||
| K-BSID III | ● | ● | ● | |||
| GAS | ● | ● | ● | |||
| PedsQL | ● | ● | ● | |||
wks weeks, GMFCS Gross Motor Function Classification System, GMFM Gross Motor Function Measure, K-BSID III Korean Bayley Scales of Infant Development III, GAS Goal Attainment Scale, PedsQL Pediatric Quality of Life Inventory