Effect of Spatial Disorientation in a Virtual Environment on Gait and Vital Features in Patients with Dementia: Pilot Single-Blind Randomized Control Trial.

Background: Orientation deficits are among the most devastating consequences of early dementia. Digital navigation devices could overcome these deficits if adaptable to the user's needs (ie, provide situation-aware, proactive navigation assistance). To fulfill this task, systems need to automatically detect spatial disorientation from sensors in real time. Ideally, this would require field studies consisting of real-world navigation. However, such field studies can be challenging and are not guaranteed to cover sufficient instances of disorientation due to the large variability of real-world settings and a lack of control over the environment.

Objective: Extending a foregoing field study, we aim to evaluate the feasibility of using a sophisticated virtual reality (VR) setup, which allows a more controlled observation of disorientation states and accompanying behavioral and physiological parameters in cognitively healthy older people and people with dementia.

Methods: In this feasibility study, we described the experimental design and pilot outcomes of an ongoing study aimed at investigating the effect of disorientation on gait and selected physiological features in a virtual laboratory. We transferred a real-world navigation task to a treadmill-based virtual system for gait analysis. Disorientation was induced by deliberately manipulating landmarks in the VR projection. Associated responses in motion behavior and physiological parameters were recorded by sensors. Primary outcomes were variations in motion and physiological parameters, frequency of disorientation, and questionnaire-derived usability estimates (immersion and perceived control of the gait system) for our population of interest. At this time, the included participants were 9 cognitively healthy older participants [5/9 women, 4/9 men; mean age 70 years, SD 4.40; Mini-Mental State Examination (MMSE) mean 29, SD 0.70) and 4 participants with dementia (2/4 women, 2/4 men; mean age 78 years, SD 2.30 years; MMSE mean 20.50, SD 7.54). Recruitment is ongoing, with the aim of including 30 cognitively healthy older participants and 20 participants with dementia.

Results: All 13 participants completed the experiment. Patients' route was adapted by shortening it relative to the original route. Average instances of disorientation were 21.40, 36.50, and 37.50 for the cognitively healthy older control, cognitively healthy older experimental participants, and participants with dementia, respectively. Questionnaire outcomes indicated that participants experienced adequate usability and immersion; 4.30 for presence, 3.73 for involvement, and 3.85 for realism of 7 possible points, indicating a good overall ability to cope with the experiment. Variations were also observed in motion and physiological parameters during instances of disorientation.

Conclusions: This study presents the first feasibility outcomes of a study investigating the viability of using a sophisticated VR setup, based on an earlier real-world navigation study, to study spatial disorientation among cognitively healthy older people and people with dementia. Preliminary outcomes give confidence to the notion that our setup can be used to assess motion and physiological markers of disorientation, even in people with cognitive decline.

Trial Registration: ClinicalTrials.gov; https://clinicaltrials.gov/ct2/show/NCT04134806.