RESTART-PD: Rehabilitation Exercise Study with Therapeutic Augmented Reality Treatment for patients with Parkinson's Disease: a randomised controlled trial of Reality DTx®

3.1 Research Question Is Reality DTx® software on augmented reality (AR) glasses to deliver rehabilitation at home, combined with reduced usual care (UC), a safe, effective and cost-effective method of improving gait and balance (Timed-Up-and-Go (TUG) test) for people with Parkinson s (PwP) compared to UC alone at 8 weeks post-randomisation? 3.2 Background NICE guidelines recommend Parkinson s-specific gait-and-balance therapy, delivered through hospital outpatient clinics. This incurs travel costs, emissions and inconvenience for PwP, restricting their ability to participate, disproportionately affecting PwP in rural communities or those of lesser means. Demand exceeds NHS capacity. Rehabilitation costs are becoming unsustainable in the UK, and unachievable in many parts of the world. A meta-analysis reported improvements in balance, gait, though using electronic games in clinic settings. Reality DTx® software on AR glasses delivers Parkinson s-specific gait-and-balance therapy in people s homes. A feasibility study showed preliminary evidence on safety, concordance, acceptability, usability and potential efficacy. 3.3 Aims and Objectives Engage NICE for set-scientific advice (month 4). Submit ethics application (5). Pre-trial qualitative study (6). Deliver 80 Reality DTx® devices to 4 NHS Trusts (9). Conduct RCT, health economics analysis and implementation study(25). Analyse data and publish the findings(36). Post-implementation toolkit for NHS adoption (36). 3.4 Methods Randomised controlled trial (RCT) Two-arm, multi-centre, superiority RCT with two parallel groups (and 6-month internal pilot). Adults with Hoehn and Yahr stage I-III Parkinson s, with gait and balance impairments, will be recruited across four sites and randomised (1:1 ratio) to six weeks of: Reality DTx® software on AR glasses to deliver rehabilitation at home or Weekly face-to-face physiotherapy for 45 minutes at outpatient physiotherapy department with a programme of unsupervised home exercises. The primary outcome is the TUG at 8 weeks post-randomisation, with final follow-up at 20-weeks. Assuming 90% power, 5% alpha, MCID=3.5 and SD=7 and 20% attrition, we need to randomise 216 participants. Economic Evaluation Within-trial cost-utility analysis to determine the incremental cost per quality-adjusted life year (QALY) of Reality DTx® over and above usual care. The base case analysis will take an NHS and personal social services costing perspective. Implementation research During trial setup: Qualitative researcher observes staff training courses and shadows healthcare personnel testing the software with patients, followed by telephone interviews with 20 patients. A stakeholder workshop actions refinements to facilitate a smooth trial. Alongside the trial: Go along interviews (informed by Patient Advisory Group) with 40 patients and 20 healthcare staff/physiotherapists to understand implementation success, patient experience and co-design recommendations for successful adoption, implementation and scale up to the wider NHS. 3.5 Delivery Timelines Total 36 months duration: 9 months set-up; 6 months internal pilot recruitment; 10 months main trial recruitment; 5 months follow-up; 6 months data cleaning, analysis and reporting. 3.6 Anticipated Impact and Dissemination Endpoint: Reality DTx® is a safe, effective, cost-effective, and scalable solution to provide Parkinson s-specific gait-and-balance therapy. Results are reported in open access journals, at professional meetings and plain language summaries are disseminated to participants and through patient advocacy organisations.