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Clinical Trials

Clinical Trials

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Funding Secured
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Evaluation & Analysis
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Project Holocue: Proof of concept study Stage 3
Eureka Eurostars: Reality DTx® - Feasibility study Stage 3
NHS Leeds: Reality DTx® - Feasibility study Stage 3

Holocue: a wearable holographic cueing application for alleviating freezing of gait in Parkinson’s disease

Project Holocue was the first scientific research conducted at the very early stages of the development of what is now Reality DTx®. Strolll acquired the IP and know-how from Vrije University in Amsterdam in 2022 and the knowledge and learnings have gone on to become part of Reality DTx® product. Two papers were published in peer-reviewed journals and are provided as a link under the named paper below.

 

Background:

 

The initial Holocue studies with first-generation mixed-reality headsets with their known limitations were primarily designed 1) to show technological feasibility of on-demand and data-based automatic cue activation in free-living environments (successful as a real-time data capturing and prediction device for gait characteristics, freezing and other motoric states and associated environmental features) and 2) to validate the need for Holocue as well as its current and anticipated conceptual design choices with potential end users (needs were well aligned with the development roadmap of NavigAIt®), it didn’t come as a surprise that the clinical feasibility study showed no immediate benefit of Holocue for reducing FOG on a group level.

 

We believe this was mainly due to the limited practice and intervention time with Holocue (about 20 minutes in total, a deliberate choice given the emphasis on collecting freezing data with the headset for the proof-of-concept studies for automatic cue activation) and known limitations of the hardware of the HoloLens 1, particularly in the size and weight of the first generation device (poor wearer comfort) and the relatively small vertical augmented-reality field of view (hampering visibility of nearby cues, thereby limiting the effect of cues because of reduced action relevance).

Geerse DJ, Coolen B, van Hilten JJ, Roerdink M (2021). Holocue: a wearable

holographic cueing application for alleviating freezing of gait in Parkinson’s

disease Frontiers in Neurology | doi: 10.3389/fneur.2021.628388.

Holocue Publication 1
granted
Michael J Fox Foundation
clinic
VU University
performed
Daphne Geerse, Associate Professor
performed
Bert Coolen
performed
Professor Melvyn Roerdink

Geerse, Daphne J. ; Coolen, Bert ; Roerdink, Melvyn. / Quantifying spatiotemporal gait parameters with hololens in healthy adults and people with Parkinson’s disease : Test-retest reliability, concurrent validity, and face validity. In: Sensors (Switzerland). 2020 ; Vol. 20, No. 11. pp. 1-12.

View Holocue Publication 2
clinic
VU University
performed
Daphne Geerse, Associate Professor
performed
Bert Coolen
performed
Professor Melvyn Roerdink

Eureka Eurostars: Feasibility trial of Reality DTx®

In December 2021, Strolll and Vrije University Amsterdam were awarded a Eureka Eurostars grant to further develop Strolll’s core product, Reality DTx®. The project lasted 18 months and two papers have been published.

Background:

 

Exergaming has the potential to increase adherence to exercise through play, individually-tailored training and (online) remote monitoring. Reality DTx® is a digital therapeutic software platform for augmented-reality glasses (AR) that enables a home-based gait-and-balance exergaming intervention specifically designed for people with Parkinson’s disease (pwPD).

 

Objective:

 

The primary objective was to evaluate the feasibility and potential efficacy of Reality DTx® AR-exergaming intervention for improving gait, balance and walking-adaptability fall-risk indicators. Secondary objective was to evaluate potential AR-glasses superiority (Magic Leap 2 [ML2] vs. HoloLens 2 [HL2]).

 

Conclusion:

 

We found that the remotely prescribed, monitored and tailored Reality DTx® intervention was feasible: it is safe for use at home, adherable, progressive-but-achievable, well-accepted and usable. Reality DTx® was potentially effective for improving gait and balance, in particular for lower-limb strength, dynamic balance and walking adaptability as indicators of reduced falls risk. Future controlled effect studies with this feasible and potentially effective Reality DTx® digital therapeutics platform are thus warranted.

 

Hardeman, L., Geerse, D., Hoogendoorn, E., Nonnekes, J., & Roerdink, M. (2023). Remotely prescribed, monitored and tailored home-based gait-and-balance exergaming intervention using augmented-reality glasses: a clinical feasibility study in people with Parkinson’s disease. Zenodo. https://doi.org/10.5281/zenodo.10425197

View Publication 1
granted
Eureka Eurostars
clinic
VU University
performed
Lotte Hardeman
performed
Daphne Geerse, Associate Professor
performed
Eva Hoogendoorn
performed
Jorik Nonnekes, Associate Professor
performed
Professor Melvyn Roerdink

Introduction:

 

External cueing can improve gait in people with Parkinson’s disease (PD), but there is a need for wearable, personalized and flexible cueing techniques that can exploit the power of action-relevant visual cues. Augmented Reality (AR) involving headsets or glasses represents a promising technology in those regards. This study examines the gait-modifying effects of real-world and AR cueing in people with PD.

 

Methods:

 

People with PD performed walking tasks augmented with either real-world or AR cues, imposing changes in gait speed, step length, crossing step length, and step height. Two different AR headsets, differing in AR field of view (AR-FOV) size, were used to evaluate potential AR-FOV-size effects on the gait-modifying effects of AR cues as well as on the head orientation required for interacting with them.

 

Results:

 

Participants modified their gait speed, step length, and crossing step length significantly to changes in both real-world and AR cues, with step lengths also being statistically equivalent to those imposed. Due to technical issues, step-height modulation could not be analyzed. AR-FOV size had no significant effect on gait modifications, although small differences in head orientation were observed when interacting with nearby objects between AR headsets.

 

Conclusion:

 

People with PD can modify their gait to AR cues as effectively as to real-world cues with state-of-the-art AR headsets, for which AR-FOV size is no longer a limiting factor. Future studies are warranted to explore the merit of a library of cue modalities and individually-tailored AR cueing for facilitating gait in real-world environments.

 

Full citation: Hoogendoorn, E., Geerse, D., van Dam, A., Stins, J., & Roerdink, M. (2024). Gait-modifying effects of augmented-reality cueing in people with Parkinson’s disease. Zenodo. https://doi.org/10.5281/zenodo.10597912

View Publication 2
granted
Eureka Eurostars
clinic
VU University
performed
Eva Hoogendoorn
performed
Daphne Geerse, Associate Professor
performed
Professor Melvyn Roerdink

NHS Leeds: Reality DTx® feasibility study

In late 2022, Strolll and NHS Leeds Teaching hospitals trust were awarded a grant by NHS Digital to run a feasibility study investigating the use of Reality DTx® software on augmented reality glasses for rehabilitation at home for adults with Parkinson’s disease.

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clinic
Leeds Teaching Hospitals NHS Trust
clinic
University of Leeds
performed
Caroline Gill
performed
Professor Rory O'Connor