Study phase | Pre-allocation | Baseline | Intervention period | Primary endpoint | Clinical follow-up | Long-term follow-upa | |||
---|---|---|---|---|---|---|---|---|---|
Timepoint | Â | Mo 0 | Weekly | Mo 1 | Mo 2 | Mo 3 | Mo 5 | Mo 8 | Mo 10, 12, 24, 48 |
Enrollment procedures | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 Clinical visit |  | X |  | X |  | X | X | X |  |
 At home | X |  | X |  | X |  |  |  | X |
 Phone screening | X |  |  |  |  |  |  |  |  |
 Written information | X | X |  |  |  |  |  |  |  |
 Verbal information | X | X |  |  |  |  |  |  |  |
 Written consent |  | X |  |  |  |  |  |  |  |
 Allocation |  | X |  |  |  |  |  |  |  |
Clinical assessments | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 Clinical examination |  | X |  |  |  |  | X |  |  |
 Peak Height Velocity |  | X |  |  |  | X | X | X |  |
 Adverse events |  | X |  | X | X | X | X | X |  |
 Previous & concomitant treatments |  | X |  | X | X | X | X | X |  |
Clinical tests | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 Pressure-Pain threshold |  | X |  | X |  | X | X | X |  |
 Knee extension strength |  | X |  | X |  | X | X | X |  |
 Countermovement jump |  | X |  | X |  | X | X | X |  |
 Modified Thomas test |  | X |  | X |  | X | X | X |  |
 Anterior knee pain provocation test |  | X |  | X |  | X | X | X |  |
Objective longitudinal measures | Â | Â | Â | ||||||
 Physical activity (sensors) |  |  |  |  |  |  |  |  |  |
Imaging | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 Ultrasound scanning |  | X |  |  |  | X | X | X |  |
Patient-reported questionnaires | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 KOOS-child 4 subscales |  | X |  | X | X | X | X | X | X |
 Patient Acceptable Symptom State |  | X |  | X | X | X | X | X | X |
 Global rating of change |  |  |  | X | X | X | X | X | X |
 Sport & Physical activity |  | X | X | X | X | X | X | X | X |
 Pain history |  | X | X | X | X | X | X | X | X |
 EuroQol 5-Dimension Youth |  | X |  |  |  | X | X | X | X |
 Tampa Scale of Kinesiophobia |  | X |  |  |  | X | X |  |  |
 Working Alliance Inventory |  |  |  |  |  | X |  |  |  |
 Miscellaneous healthb |  | X |  |  |  |  |  |  |  |
 Pubertal stage (Tanner) |  | X |  |  |  | X | X |  |  |
 Adherence to treatments |  |  | X | X |  | X | X | X |  |
Intervention | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 Experimental or usual care treatment |  |  |  |  | |||||
 Complete self-management |  |  |  |  |  |  |  |