PMID- 35637495 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220716 IS - 2055-5784 (Print) IS - 2055-5784 (Electronic) IS - 2055-5784 (Linking) VI - 8 IP - 1 DP - 2022 May 30 TI - Gait rehabilitation for foot and ankle impairments in early rheumatoid arthritis: a feasibility study of a new gait rehabilitation programme (GREAT Strides). PG - 115 LID - 10.1186/s40814-022-01061-9 [doi] LID - 115 AB - 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. CI - (c) 2022. The Author(s). FAU - Hendry, Gordon J AU - Hendry GJ AUID- ORCID: 0000-0003-1611-7193 AD - School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK. gordon.hendry@gcu.ac.uk. FAU - Bearne, Lindsay AU - Bearne L AD - Department of Population Health Sciences, King's College London, London, UK. AD - Centre for Applied Health and Social Care Research, Kingston University and St George's, University of London, London, UK. FAU - Foster, Nadine E AU - Foster NE AD - School of Medicine, Keele University, Newcastle, UK. AD - STARS Education Alliance, Surgical Treatment and Rehabilitation Service (STARS), The University of Queensland and Metro North Health, Herston, Queensland, Australia. FAU - Godfrey, Emma AU - Godfrey E AD - Department of Population Health Sciences, King's College London, London, UK. FAU - Hider, Samantha AU - Hider S AD - School of Medicine, Keele University, Newcastle, UK. AD - Midlands Partnership Foundation Trust, Stafford, UK. FAU - Jolly, Lisa AU - Jolly L AD - Clinical Research and Development, NHS Greater Glasgow and Clyde, Glasgow, UK. FAU - Mason, Helen AU - Mason H AD - Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UK. FAU - McConnachie, Alex AU - McConnachie A AD - Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK. FAU - McInnes, Iain B AU - McInnes IB AD - Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK. FAU - Patience, Aimie AU - Patience A AD - School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK. FAU - Sackley, Catherine AU - Sackley C AD - Department of Population Health Sciences, King's College London, London, UK. AD - School of Health Sciences, University of Nottingham, Nottingham, UK. FAU - Sekhon, Mandeep AU - Sekhon M AD - Department of Population Health Sciences, King's College London, London, UK. FAU - Stanley, Bethany AU - Stanley B AD - Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK. FAU - van der Leeden, Marike AU - van der Leeden M AD - Amsterdam University Medical Centre/Reade, Amsterdam, The Netherlands. FAU - Williams, Anita E AU - Williams AE AD - School of Health and Society, University of Salford, Salford, UK. FAU - Woodburn, Jim AU - Woodburn J AD - School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK. AD - School of Health Sciences and Social Work, Griffith University, Gold Coast, Queensland, Australia. FAU - Steultjens, Martijn P M AU - Steultjens MPM AD - School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK. LA - eng GR - 15/165/Health Technology Assessment Programme/ PT - Journal Article DEP - 20220530 PL - England TA - Pilot Feasibility Stud JT - Pilot and feasibility studies JID - 101676536 PMC - PMC9150324 OTO - NOTNLM OT - Feasibility OT - Gait rehabilitation OT - Rheumatoid arthritis COIS- The authors declare that they have no competing interests. EDAT- 2022/06/01 06:00 MHDA- 2022/06/01 06:01 PMCR- 2022/05/30 CRDT- 2022/05/31 14:07 PHST- 2021/11/29 00:00 [received] PHST- 2022/05/04 00:00 [accepted] PHST- 2022/05/31 14:07 [entrez] PHST- 2022/06/01 06:00 [pubmed] PHST- 2022/06/01 06:01 [medline] PHST- 2022/05/30 00:00 [pmc-release] AID - 10.1186/s40814-022-01061-9 [pii] AID - 1061 [pii] AID - 10.1186/s40814-022-01061-9 [doi] PST - epublish SO - Pilot Feasibility Stud. 2022 May 30;8(1):115. doi: 10.1186/s40814-022-01061-9.