Abstract

BACKGROUND: Foot impairments in early rheumatoid arthritis are common and lead to progressive deterioration of lower limb function. A gait rehabilitation programme underpinned by psychological techniques to improve adherence, may preserve gait and lower limb function. This study evaluated the feasibility of a novel gait rehabilitation intervention (GREAT Strides) and a future trial. METHODS: This was a mixed methods feasibility study with embedded qualitative components. People with early (< 2 years) rheumatoid arthritis (RA) and foot pain were eligible. Intervention acceptability was evaluated using a questionnaire. Adherence was evaluated using the Exercise Adherence Rating Scale (EARS). Safety was monitored using case report forms. Participants and therapists were interviewed to explore intervention acceptability. Deductive thematic analysis was applied using the Theoretical Framework of Acceptability. For fidelity, audio recordings of interventions sessions were assessed using the Motivational Interviewing Treatment Integrity (MITI) scale. Measurement properties of four candidate primary outcomes, rates of recruitment, attrition, and data completeness were evaluated. RESULTS: Thirty-five participants (68.6% female) with median age (inter-quartile range [IQR]) 60.1 [49.4-68.4] years and disease duration 9.1 [4.0-16.2] months), were recruited and 23 (65.7%) completed 12-week follow-up. Intervention acceptability was excellent; 21/23 were confident that it could help and would recommend it; 22/23 indicated it made sense to them. Adherence was good, with a median [IQR] EARS score of 17/24 [12.5-22.5]. One serious adverse event that was unrelated to the study was reported. Twelve participants' and 9 therapists' interviews confirmed intervention acceptability, identified perceptions of benefit, but also highlighted some barriers to completion. Mean MITI scores for relational (4.38) and technical (4.19) aspects of motivational interviewing demonstrated good fidelity. The Foot Function Index disability subscale performed best in terms of theoretical consistency and was deemed most practical. CONCLUSION: GREAT Strides was viewed as acceptable by patients and therapists, and we observed high intervention fidelity, good patient adherence, and no safety concerns. A future trial to test the additional benefit of GREAT Strides to usual care will benefit from amended eligibility criteria, refinement of the intervention and strategies to ensure higher follow-up rates. The Foot Function Index disability subscale was identified as the primary outcome for the future trial. TRIAL REGISTRATION: ISRCTN14277030.