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Table 2 Outcome measurements

From: Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study

  

STUDY PERIOD

  

Enrolment/ Baseline

Post-allocation

Close-out

TIMEPOINTa

t0

t1

t2

ENROLMENT:

 Eligibility screen

X

  

 Informed consent

X

  

 Allocation

X

  

INTERVENTIONS:

 Foot exercise and education

   

 Brief advice

   

ASSESSMENTS:

 Participant characteristics

X

  

Primary outcome measures

Feasibility

  Number of eligible participants

  

X

  Willingness to enrol

  

X

  Recruitment rate

  

X

  Adherence

  

X

  Logbook completion

  

X

  Adverse effects

  

X

  Dropout rates

  

X

Credibility

  Borkovec and Nau Questionnaire

X

X

 

Acceptability

  Number of sessions attended

  

X

  Adherence to foot exercises

  

X

  Additional treatment sought

  

X

  Early withdrawal

  

X

Secondary outcome measures

Patient reported outcomes

  First step pain in previous week

X

X

 

  Worst pain in previous week

X

X

 

  Average pain in previous week

X

X

 

  Foot and Ankle Ability Measure

X

X

 

  Foot Health Status Questionnaire

X

X

 

  Global Rating of Change Score

 

X

 

  Pain Self-Efficacy Scale

X

X

 

  Active Australia Survey

X

X

 

Physical measurements

  Intrinsic foot muscle morphology (MRI & ultrasound)

X

X

 

  Plantar fascia thickness (ultrasound)

X

X

 

  Intrinsic foot muscle motor performance

X

X

 

  Foot Posture Index

X

X

 

  Foot mobility

X

X

 

 Ankle dorsiflexion range of motion (standing lunge test)

X

X

 

  Toe flexor strength (dynamometry)

X

X

 

  Plantar flexor strength (standing heel rise test)

X

X

 
  1. at0 = Baseline, t1 = week 12, t3 = end of data collection all participants