The GREAT trial
Gait Rehabilitation in Early Arthritis Trial
Summary
Multicentre randomised controlled trial (RCT) design where patients are individually randomised on a 1:1 allocation ratio to receive either usual care or usual care plus intervention.
The intervention is treatment sessions over 12 weeks to guide participants for undertaking a gait rehabilitation programme comprised of functional walking tasks and will include a supported home-based gait rehabilitation programme and an embedded psychological component to promote positive sustainable change.
| Chief Investigator: |
Prof Martijn Steultjens (Glasgow Caledonian University) |
| Associate Investigator: |
Gordon Hendry (Glasgow Caledonian University) Local PI – Dr Samantha Hider |
| Trial Manager: |
Central – Lisa Jolly Local – Sarah Bathers |
| Sponsor / Reference Number: | Keele University |
| Funder / Reference Number: | National Institute for Health Research – Health Technology Assessment Programme / 15/165/04 |
| UKCRN Study Portfolio Reference Number: | 38124 |
| Registration Reference Number: | ISRCTN18132064 |
| Start Date: | 31 Oct 2017 |
| End Date: | Oct 2024 |
Aim and objectives
Does the addition of a specifically designed gait rehabilitation programme to standard care improve lower limb function in early rheumatoid arthritis patients?
Objectives for main trial phase:
- To compare the clinical effectiveness of the addition of a new gait rehabilitation intervention to usual care versus usual care alone on lower limb function
- To compare the cost-effectiveness of the addition of a new gait rehabilitation intervention to usual care versus usual care alone
- To evaluate participants’ view and experiences of the usual care and gait rehabilitation interventions.
- To evaluate intervention therapists’ (physiotherapists and podiatrists) view and experiences of the usual care and gait rehabilitation interventions and trial processes.