Pre-study screening/consent | Baseline | Randomisation /Clinical visit 1 | Clinical visit 2 | Clinical visit 3 | 6 months follow up | 12 months follow up | |
---|---|---|---|---|---|---|---|
−1 | 0 | T1a | T2b | T3 | F1 | F2 | |
Enrolment | |||||||
Eligibility screen | X | ||||||
Informed consent | X | ||||||
Allocation | X | ||||||
Measurements | |||||||
FFI pain | X | X | X | ||||
FFI disability | X | X | X | ||||
FFI functional limitation | X | X | X | ||||
FIS-RA | X | X | X | ||||
EQ-5D-5 L | X | X | X | ||||
HAQ | X | X | X | ||||
DAS-28 | X | X | X | ||||
CSRI | X | X | |||||
Interventions | |||||||
Customised foot orthoses | X | X | X | ||||
Prefabricated foot orthoses | X | X |