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Table 3 SPIRIT figure. Schedule of enrolment, interventions and assessments

From: The Foot Orthoses versus Hip eXercises (FOHX) trial for patellofemoral pain: a protocol for a randomized clinical trial to determine if foot mobility is associated with better outcomes from foot orthoses

  

Trial period

 

Enrolment

Allocation

Intervention period

Follow up

Close out

 

May 2014– November 2016

May 2014– November 2016

Week 1

Week 2

Week 3

Week 4

Week 5

Week 6

Week 6

August 2014 – Feb 2017

Enrolment

 Eligibility screening

X

         

 Informed Consent

X

         

 Allocation

 

X

        

Intervention

 Foot orthoses

  

X

X

X

X

X

X

  

 Hip exercises

  

X

X

X

X

    

Assessment

 Diagnosis

X

         

 Midfoot width mobility

X

         

 Demographics

 

X

        

 Global rating of change

        

X

X

 Rate of recovery

        

X

X

 Patient acceptable symptom state

        

X

X

 Numerical pain rating

 

X

      

X

X

 PSFS

 

X

      

X

X

 Kujala

 

X

      

X

X

 KOOS

 

X

      

X

X

 HADS

 

X

      

X

X

 Euro-QoL

 

X

      

X

X

 TSK

 

X

      

X

X

 PCS

 

X

      

X

X

 Functional tests: step up, step down, squat

 

X

      

X

X

 Navicular height

 

X

       

X

 Midfoot height mobility

 

X

       

X

 Isometric hip strength testing

 

X

      

X

X

 Range of motion measures

 

X

      

X

X

  1. Kujala Kujala patellofemoral pain scale, PSFS patient specific functional scale, KOOS knee injury and osteoarthritis outcome scale, HADS hospital anxiety and depression scale, TSK Tampa scale for kinesophobia, PCS pain catastrophising scale