Feasibility outcomes
RECRUITMENT, SECONDARY
Our primary aim was to determine feasibility (criteria shown in Consent rate (number consented from those eligible after screening for inclusion/exclusion criteria)Intervention fidelity in the intervention group (measured as a binary outcome if participants were given the orthosis, taught the progressive exercise regimen and received advice/education on a minimum of 6 of the 12 specified topics)Attendance rate in the intervention group (number of physiotherapy appointments attended from the total appointments booked)Outcome measure completion rate at six months post-randomisationFeasibility criteria for a future main trial.Recruitment feasibility of 25% was selected based upon 50 patients being recruited from 200 patients referred per year – data that the three sites had provided from historic referral patterns. The fidelity criterion was determined by the research team as no precedent has been set. Attendance rate of 70% was set based upon previously published data for physiotherapy outpatient attendance (The secondary aims were to assess:Outcome measure completion rate at 6 weeks and 12 weeks post-randomisationCompletion of a grip-strength physical measure at two time points using the Squegg devicePatient-reported outcome measures (PROMs) at baseline, 6 weeks, 12 weeks and 6 months post-randomisation (analysed descriptively)Responsiveness to change analysis of individual PROMs questionnaires compared with patient perceived overall treatment effect, to determine the most appropriate PROMs for a future trialAdherence to exercise therapy treatment (measured using a self-reported exercise diary and Exercise Adherence Rating Scale (EARS))(Acceptability of the optimised physiotherapy treatment package and trial processes, investigated through the nested qualitative study