Feasibility and multi-centre clinical trial of gait rehabilitation in patients with recently diagnosed rheumatoid arthritis: the Gait Rehabilitation in Early Arthritis Trial [GREAT]
People with early rheumatoid arthritis are being asked to walk through a circuit of functional tasks—stepping over obstacles, changing direction, pacing themselves—as part of a supervised gait rehabilitation programme, tested against usual NHS care. This matters because foot and ankle pain is one of the most disabling features of early rheumatoid arthritis, yet there is no standard, evidence-based gait rehabilitation programme for these patients. Current care is ad hoc: some patients see a physiotherapist or podiatrist, many do not, and no one knows whether a structured walking programme actually improves their mobility or quality of life. If the trial shows that gait rehabilitation works and is cost-effective, the NHS could adopt a standardised, deliverable intervention—requiring only existing physiotherapists or podiatrists—that helps people with early rheumatoid arthritis walk better, stay active, and avoid long-term disability. The embedded psychological component to promote adherence means the programme is designed for real-world uptake, not just lab conditions. The health economic evaluation will tell funders whether the benefits justify the cost.
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Design: Mixed methods feasibility phase and a pragmatic multi-centre 2-arm RCT with internal pilot phase, process evaluation and health economic evaluation. Setting: NHS hospital/community physiotherapy or podiatry clinics. Population: Adults with a diagnosis of RA with less than 2 years disease duration who have foot and/or ankle pain and/or synovitis. Inclusions: Diagnosis of RA; RA less than 2 years disease duration; aged 18+ years; willing to participate. Exclusions: Patients unable to complete the intervention as identified by their consultant rheumatologist or the recruiting clinician at screening; unable or unwilling to provide informed consent; currently taking part in other non-medical intervention studies targeting improved lower limb function and/or gait. Health technologies: In addition to usual care, participants will receive supervised gait rehabilitation comprising 2 to 6 1:1 treatment sessions over 12 weeks to guide participants for undertaking a gait rehabilitation circuit comprised of functional walking tasks. Intervention dose and progression will be individualised, and will include a supported home-based gait rehabilitation circuit and an embedded psychological component to promote positive behavioural change. Telephone-based sessions will be provided to maintain contact, promote adherence, and provide progression advice. The ingredients of the intervention have been adapted from existing programmes for improving balance, strength and walking ability in older adults and established RA. The intervention will be delivered by existing NHS physiotherapists or podiatrists. Comparator: Usual rheumatology medical management and referrals to physiotherapy and/or podiatry as required. All care received will be recorded. Outcomes and costs: The best performing primary outcome measure will be selected from evaluation of the responsiveness-to-change of 4 candidates in the feasibility phase: the Foot Function Index disability subscale, PROMIS physical function scale, ROAD lower extremity scale, and 10m walking speed. Secondary outcomes include: activities of daily living; health related-quality of life; exercise self-efficacy; physical activity. Healthcare resource use will be recorded. Outcomes will be collected at 3, 6 and 12 months from baseline by postal questionnaire. Sample size: To detect an effect size of 0.31 (mean difference 10, SD 32 on the FFIdis, 90% power, two-tailed significance of 5% and assuming 20% loss to follow-up, 550 participants will be recruited. Sample size will be checked upon completion of the internal pilot. Analysis: The primary (intention-to-treat) analysis will use a linear regression model of the primary outcome at 6 months, adjusted for baseline measurement of the primary outcome and all minimisation variables. Cost effectiveness and cost-utility analyses will be assessed using the primary outcome and the EQ-5D-5L from NHS and societal perspectives. Timetable: 60 months total project; set up 9 months; feasibility 12 months; internal pilot 9 months; main trial recruitment from 12-15 sites over 18 months; data collection over 24 months; analysis and report 3 months. Expertise in team: A multidisciplinary team comprising trialists, experts in rehabilitation research for RA, musculoskeletal pain and disability, rheumatology, physiotherapy, podiatry, psychology, statistics, health economics, mixed-methods and qualitative research and patient representatives.
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