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.