Gait Rehabilitation in Early Arthritis Trial - GREAT
Research type
Research Study
Full title
Feasibility and multi-centre clinical trial of gait rehabilitation in patients with recently diagnosed rheumatoid arthritis: the Gait Rehabilitation in Early Arthritis Trial
IRAS ID
236560
Contact name
Gordon Hendry
Contact email
Sponsor organisation
Glasgow Caledonian University
ISRCTN Number
ISRCTN14277030
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
Almost all patients with RA will develop foot and ankle pain. During the first two years of RA, patients receive medications to control inflammation and may
be referred to physiotherapy and/or podiatry for stretching/strengthening exercises and insoles. Gait rehabilitation has been used with success in neurological conditions but its effectiveness in RA remains unknown. We have developed a gait rehabilitation intervention for people with early RA which involves patients undertaking repetitions of walking tasks. This will be done under supervision by a physiotherapist or podiatrist initially, with support for completion of the walking tasks at home.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.
A large trial following the feasibility phase is planned to investigate whether gait rehabilitation adds benefits to usual care. We will recruit 550 patients who 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.
We will measure intervention acceptability, adherence and safety after 12 weeks
using postal questionnaires and interviews with a subgroup of participants as well as clinicians who delivered the intervention. At 3 additional timepoints we will ask patients to complete postal questionnaires to determine their walking ability/lower limb function, ability to do daily activities, their quality of life, their ability to undertake exercise and levels of physical activity.Upon completion of the feasibility, this project will progress to an internal pilot trial (ethical and R&D approval to be sought separately).
REC name
West of Scotland REC 3
REC reference
17/WS/0264
Date of REC Opinion
9 Feb 2018
REC opinion
Further Information Favourable Opinion