Table 2.
Outcome measurements
| 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 | ||
at0 = Baseline, t1 = week 12, t3 = end of data collection all participants