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Table 3 Summary of standard protocol items

From: Footwear, foot orthoses and strengthening exercises for the non-surgical management of hallux valgus: protocol for a randomised pilot and feasibility trial

 

T0

T1

Baseline

(lab)

T2

4 weeks

(postal)

T3

8 weeks

(postal)

T4

12 weeks

(lab)

Postal invitation

X

    

Telephone screening

X

    

Informed consent

 

X

   

Baseline assessments

 Medical history questionnaires

 

X

   

 3D foot scanning

 

X

  

X

 Biomechanical assessment

 

X

   

 Randomisation

 

X

   

 Receive intervention

 

X

   

 CEQ

 

X

   

 MOS (intervention group only)

 

X

  

X

Outcome measures

 MOXFQ

 

X

X

X

X

 Muscle strength

 

X

  

X

 SF-12

 

X

X

X

X

 Use of cointerventions

 

X

X

X

X

 Incidental and planned activity questionnaire

 

X

X

X

X

 Perception of overall treatment effect

  

X

X

X

Adherence

 Footwear/orthoses

 

continuous (Orthotimer®)

 Exercise

 

continuous (PhysiTrack® app)

 Adverse events

 

X

X

X

X