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Table 2 Study schedule

From: Self-management including exercise, education and activity modification compared to usual care for adolescents with Osgood-Schlatter (the SOGOOD trial): protocol of a randomized controlled superiority trial

Study phase

Pre-allocation

Baseline

Intervention period

Primary endpoint

Clinical follow-up

Long-term follow-upa

Timepoint

 

Mo 0

Weekly

Mo 1

Mo 2

Mo 3

Mo 5

Mo 8

Mo 10, 12, 24, 48

Enrollment procedures

         

 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

         

 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

         

 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

   

 Physical activity (sensors)

         

Imaging

         

 Ultrasound scanning

 

X

   

X

X

X

 

Patient-reported questionnaires

         

 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

         

 Experimental or usual care treatment

    

 Complete self-management

       
  1. a= digital, b= Sleep duration and problems, vitamin and supplement consumption. PA Physical activity, QoL Quality of Life