About
Rheumatoid Arthritis is a chronic autoimmune disease that attacks multiple joints throughout the body. There are an estimated 645,000 people with RA in the UK and more than 90% of people with the disease develop symptoms in the foot and ankle, with resulting difficulties in walking. Many people with RA are unable to walk far or fast, and often struggle with mobility tasks such as climbing stairs and walking on uneven ground.
During the first two years of diagnosis, patients usually receive medication to control inflammation and may be referred for physiotherapy and/or podiatry for stretching and strengthening exercises and insoles. While some patients improve, many continue to suffer from foot pain, walking difficulties and problems performing daily activities.
The GREAT Study will examine the effectiveness of a new way of improving and maintaining walking ability in people who suffer from the painful and disabling symptoms of early RA. Gait rehabilitation has been proven to help patients with mobility issues resulting from neurological conditions such as stroke, multiple sclerosis and Parkinson’s disease but its effectiveness in RA remains unknown.
Experts in rehabilitation research for rheumatoid arthritis, musculoskeletal pain and disability, rheumatology, physiotherapy, podiatry, psychology, statistics, health economics, mixed-methods and qualitative research and patient representatives will be involved in the trial. The technique involves undertaking repetitive tasks using a walking circuit, such as stepping over obstacles, combined with behavioural approaches, and aims to help improve posture, balance and stability. The exercises will be done under supervision by a physiotherapist or podiatrist initially, with support for completion of the walking tasks at home.
The work will involve an initial feasibility study with patients from NHS regions in Scotland and England, followed by a large trial to investigate whether gait rehabilitation should be offered to all people in the early stages of the disease. Gait rehabilitation has the potential to improve and maintain walking ability in early RA, prevent functional deterioration and promote more physically active lifestyles. The study will also increase awareness of the importance of preserving walking ability early in the disease course of RA.
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The research was funded by the National Institute for Health Research Health Technology Assessment Programme (NIHR HTA). The views expressed are not necessarily those of the NHS, the NIHR or the Department of Health.
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For further information, visit the NIHR website.
Project Summary
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Background
Almost all patients with RA will develop foot and ankle pain and will experience difficulties with walking as a result. Patients walk slower and are more unsteady on their feet, and they often reduce their daily activities due to pain causing loss of muscle strength, balance and stability. During the first two years of RA, patients usually receive medications to control inflammation and may be referred to physiotherapy and/or podiatry for stretching/strengthening exercises and insoles. Whilst some patients improve, many continue to suffer from foot pain, walking difficulties and performing daily activities.
Gait rehabilitation has been used with success in neurological conditions but its effectiveness in RA remains unknown.
We have developed a new gait rehabilitation intervention for people with early RA which involves patients undertaking repetitions of walking tasks such as stepping over obstacles. This will be done under supervision by a physiotherapist or podiatrist initially, with support for completion of the walking tasks at home.
We will evaluate whether adding this gait rehabilitation intervention to usual treatment results in any additional benefit compared to usual treatment alone in a randomised trial.
Plan
First, we will conduct a feasibility study of 42 participants with early RA (within 2 years of diagnosis) to 1) identify the best way to measure the effectiveness of the gait rehabilitation intervention;
2) determine its acceptability and safety; and
3) determine whether it can be delivered as intended.
Next, we will conduct a miniature version of the main trial to identify whether enough eligible patients can be recruited and kept in the study.
Lastly, we plan a large trial to investigate whether gait rehabilitation adds benefits to usual care. Adults with early RA and foot and ankle pain who meet other criteria for inclusion will be invited to take part and asked to sign a consent form.
Recruitment
Feasibility: We will recruit 42 participants over 6 months from 3 NHS Trusts/Health Board regions in Scotland and England. They will all receive usual care plus gait rehabilitation over 12 weeks.
Trial: We will recruit 550 patients over 26 months from 12-15 NHS Trusts/Health Board
regions in Scotland and England. Patients will be allocated by chance to one of two treatments: 1. Usual rheumatology care including physiotherapy and podiatry as required. 2. The same as in 1. Plus gait rehabilitation, delivered over 2-6 sessions over 12 weeks and supplemented with a home programme.
Method
Feasibility: We will measure intervention acceptability, adherence and safety after 12 weeks using postal questionnaires and interviews with a small subgroup of participants as well as clinicians who delivered the intervention. We will compare 4 measurement tools to determine the best tool to measure change in response to the intervention in the main trial.
Trial: At 3, 6 and 12 months we will ask patients to complete and return postal questionnaires to find out about their walking ability/lower limb function, ability to do daily activities, their quality of life, their ability to undertake exercise and their levels of physical activity. We will also evaluate the amount of healthcare they have received to work out the costs of the new and usual care interventions in relation to any benefits achieved. This data will be used to establish whether or not gait rehabilitation should be offered to people with early RA in future.