Remotely prescribed and monitored home-based gait-and-balance therapeutic exergaming using augmented reality (AR) glasses: protocol for a clinical feasibility study in people with Parkinson’s disease

Abstract

Abstract Background Clinical guidelines for people with Parkinson’s disease (pwPD) stress that, complementary to pharmacological treatment, exercise and physiotherapy should be given a central role in disease management. Adhering to regular exercise of the right type, and with high repetition, remains a challenge for pwPD. Exergaming has the potential to increase adherence through play and personalised interventions, both in clinic and at home. Reality DTx® is an augmented-reality (AR) home-based gait-and-balance exergaming intervention specifically designed for pwPD as an extension of supervised physiotherapy. The primary objective of this study is to evaluate the feasibility and potential efficacy of Reality DTx®. Methods Twenty-four pwPD (Hoehn and Yahr stages 2–4) with self-reported gait and/or balance impairments will participate in this study. The study comprises a 6-week waitlist-controlled AR home-based therapeutic gait-and-balance exergaming intervention. Reality DTx® will initially be prescribed remotely for a minimum of 5 days a week for 30 min per day. We will remotely set and adjust the frequency, difficulty, type of games, and/or duration weekly, based on objective and subjective data from the AR glasses and participant, respectively. In addition to the home-based gait-and-balance exergaming intervention, the study comprises three laboratory visits: before the 6-week waitlist period (t0; baseline), before the 6-week intervention period (t1; pre-intervention), and after the 6-week intervention period (t2; post-intervention). The primary study parameters are feasibility (in terms of safety, adherence, and user experience) and potential efficacy for improving gait and balance (using standard clinical gait-and-balance tests and a targeted walking-related fall-risk assessment). Recruitment started in December 2022 and the final post-intervention assessment will be according to planning in July 2023. Conclusions This clinical feasibility trial is the first remotely prescribed and monitored home-based AR gait-and-balance exergaming intervention for pwPD. The results in terms of clinical feasibility (i.e. safety, adherence, and user experience) and potential efficacy (gait, balance, and fall-risk outcomes) form the basis for future randomised controlled studies on the effectiveness of home-based AR gait-and-balance exergaming interventions for pwPD. Trial registration ClinicalTrials.gov, NCT05605249. Registered on 4 November 2022.