A Randomized Clinical Trial to Evaluate a Digital Therapeutic to Enhance Gait Function in Individuals With Parkinson’s Disease

Abstract

Background Postural instability and gait dysfunction (PIGD) is a cardinal symptom of Parkinson’s disease (PD) and is exacerbated under dual-task conditions. Dual-task training (DTT), enhances gait performance, however it is time and cost intensive. Digitizing DTT via the Dual-task Augmented Reality Treatment (DART) platform can expand the availability of an effective intervention to address PIGD. Objective The aim of this project was to evaluate DART in the treatment of PIGD in people with PD compared to a Traditional DTT intervention. It was hypothesized that both groups would exhibit significant improvements in gait, and the improvements for the DART group would be non-inferior to Traditional DTT. Methods A single-blind randomized controlled trial was conducted with 47 PD participants with PIGD. Both groups completed 16 therapeutic sessions over 8 weeks; the DART platform delivered DTT via the Microsoft HoloLens2. Primary outcomes included clinical ratings and single- and dual-task gait biomechanical outcomes. Results Clinical measures of PD symptoms remained stable for DART and Traditional DTT groups. However, both groups exhibited a significant increase in gait velocity, cadence, and step length during single- and multiple dual-task conditions following the interventions. Improvements in gait velocity in the DART group were non-inferior to Traditional DTT under the majority of conditions. Conclusion Non-inferior improvements in gait parameters across groups provides evidence of the DART platform being an effective digital therapeutic capable of improving PIGD. Effective digital delivery of DTT has the potential to increase use and accessibility to a promising, yet underutilized and difficult to administer, intervention for PIGD. Clinical Trial Registration ClinicalTrials.gov Dual-task Augmented Reality Treatment for Parkinson’s Disease (DART) NCT04634331; posted November 18, 2020.

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

“…We therefore conclude that people with PD can adjust various aspects of their gait to variations in AR cues, and that they do this as effectively as to real-world cues. These findings, corroborating related work in healthy adults ( 29 , 44 ), are relevant for recent studies that have already implemented AR cues in training interventions like dual-task training for people with PD, which showed promising results ( 20 , 45 ).…”

“…In doing so, one could ultimately take advantage of the flexibility (selecting the most effective type of cue) and personalization (tailoring the cues to individual’s gait characteristics) potential of AR cueing, as cueing is not a one-size-fits-all principle ( 1 , 17 ). Additional benefits that AR-cueing applications may offer besides flexibility and personalization are (i) multimodality (e.g., visual cues, auditory cues, or both), (ii) cue activation [e.g., making use of headset-data features ( 20 ), on-demand activation with voice commands ( 23 ) or intelligent open-loop vs. closed-loop cueing ( 57 )] and (iii) spatial awareness (e.g., merging visual cues to features in mapped environments). The latter seems particularly useful when transitioning from the lab (as in the current study) toward implementation in the home environment of people with PD, as was already explored by Geerse et al ( 23 ).…”

“…One emerging technology to accommodate these requirements may be Augmented Reality (AR) ( 18 , 19 ), involving software applications for wearable headsets or glasses through which the user’s environment can be augmented with visual holographic, digital objects. Recent studies have shown potential for providing AR cueing and training programs for people with PD to improve gait and balance ( 20 – 23 ), which raised interest for implementing cues in AR. AR breaks the boundaries of physical visual cues with the possibility of projecting holographic visual cues anywhere, anytime.…”

“…Even though early AR cueing research in people with PD with the first-generation AR headsets did not find any significant improvements on FoG, the results were still encouraging as subjective benefits of AR cueing are often reported ( 23 – 25 ). The lack of positive findings may be related to the limited AR field of view (AR-FOV) of the AR headsets ( 18 , 23 , 26 , 27 ), an insufficient familiarization period to AR headsets ( 23 ), the fact that only one specific visual cue was implemented ( 1 , 17 ), or the emphasis on FoG as an outcome measure instead of other valuable gait characteristics like gait speed and step length, susceptible to improvement with AR cueing ( 20 , 25 , 28 , 29 ). In the present study we address these issues.…”

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

“…This tentatively improves the confidence of inclusion/exclusion of people with HY3 and enables supervised in-clinic exergaming scenarios for people with HY4 (see iii); iii. Extending the number of exergames: To target other aspects of motor and/or cognitive impairments [e.g., dual-tasking (14,23,24,49)], to include those at higher HY stages with tailored game-play settings (e.g., playing when seated), and to increase long-term adherence (e.g., playing the same five exergames may become less engaging or motivating over a longer period); iv. Considering changing outcome measures: The observed intervention effects of Reality DTx ® were convincing for improving targeted fall-risk indicators associated with walking adaptability, fitting the nature of the exergames.…”