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

BACKGROUND Clinical guidelines for people with Parkinson's disease (pwPD) stress that, complementary to pharmacological treatment, exercise and physical therapy should be given a central role to 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 gamified gait-and-balance exergaming intervention specifically designed for pwPD as an extension of supervised physical therapy. The primary objective of this study is to evaluate the feasibility and potential efficacy of Reality DTx®. METHODS Twenty-four individuals with PD (Hoehn & Yahr stage 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 minimally five days a week for 30 minutes per day. We will remotely set and adjust the frequency, difficulty, type of games and/or duration on a weekly basis, 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 according to planning be 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 4 November 2022, https://clinicaltrials.gov/ct2/show/NCT05605249

Gait-modifying effects of augmented-reality cueing in people with Parkinson’s disease

“…This study was approved by the accredited Medical research Ethics Committees United (MEC-U), the Netherlands (R22.076, NL82441.100.22). Individuals with PD who participated in a clinical feasibility study on home-based gait-and-balance exergaming with AR headsets ( 21 , 31 ) were invited to participate in the current study. The benefit of recruiting participants from this clinical feasibility study was that participants were already familiar with AR headsets for at least 3 weeks.…”

Remotely prescribed, monitored, and tailored home-based gait-and-balance exergaming using augmented reality glasses: a clinical feasibility study in people with Parkinson’s disease

“…Here, we summarize the methods used in this study. A detailed study protocol was pre-registered ( 25 ), while (minor) changes thereto are specified below.…”

“…Various complementary outcomes of potential efficacy for improving gait and balance were evaluated in the laboratory (t0, t1, and t2), using clinical gait-and-balance tests and adaptive-walking tasks like obstacle avoidance with the Interactive Walkway ( Figure 3 ), which allowed for more in-depth targeted fall-risk assessment. Complementary feasibility outcomes were derived from the web portal (adherence and performance scores), telephone calls (safety and technical issues), and online questionnaires (acceptability and user experience) during (t1-t2) or after (>t2) the intervention as specified in Supplementary material S2 and detailed in the pre-registration ( 25 ).…”

“…The authors would like to thank Jara van Bergem, Annelotte Geene, and Annejet van Dam for their help with performing the measurements. The article is available as a preprint on Zenodo ( 25 ).…”