Gait Rehabilitation in Early Arthritis Trial - Pilot and Main Trial

• Research type

  Research Study

• Full title

  The Gait Rehabilitation in Early Arthritis Trial

• IRAS ID

  263073

• Contact name

  Martijn Steultjens

• Contact email

  martijn.steultjens@gcu.ac.uk

• Sponsor organisation

  Glasgow Caledonian University

• ISRCTN Number

  ISRCTN14277030

• Duration of Study in the UK

  2 years, 9 months, 30 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.

  This RCT trial follows 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 2-4 sessions over 12 weeks and supplemented with a home programme.
  We will measure intervention acceptability, adherence and safety after 12 weeks
  using questionnaires and interviews.
  A subgroup of participants and clinicians who delivered the intervention will be interviewed.
  At 2 additional timepoints, 6 months and 12 months, we will ask patients to complete 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.

• REC name

  West of Scotland REC 5

• REC reference

  19/WS/0189

• Date of REC Opinion

  17 Dec 2019

• REC opinion

  Favourable Opinion