Remotely Prescribed and Monitored Home-based Gait-and-balance Augmented Reality Exergaming for People With Parkinson's Disease.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2023-07-05

Brief Summary

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Despite optimal treatment with medication, people with Parkinson's disease (PD) still experience symptoms and secondary complications. Physiotherapy has long been recognized as one of the leading treatments in PD for slowing progression of the disease and retaining a higher quality of life for longer. Physiotherapy includes, among other things, training motor functions e.g., gait, balance and strength training and encourages physical activity. Exercise is an important part of healthy living for everyone, but for people with PD, exercise is medicine. Studies even suggest that exercise may slow down disease progression. Another way of improving PD motor symptoms, such as festination and freezing of gait (FOG), in a more direct way is by sensory cueing. Cueing is defined as the application of spatial or temporal external stimuli to help initiate, or facilitate gait, and can be presented as acoustic, visual, or tactile stimuli. It has been well known for many years that sensory cueing is effective and there has been extensive research on the topic.

Cue X is a new product developed by Strolll Limited (www.strolll.co) that applies the existing proven principles of exercise and sensory cueing for PD onto augmented-reality (AR) headsets implemented in two modules: movement training and movement assistance. The movement training module is designed to train gait and balance in a gamified manner to maximize training compliance. With this clinical feasibility study, the investigators want to examine the feasibility and potential efficacy of the Cue X movement training module to train gait and balance of people with PD in their home environment.

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Detailed Description

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The primary objective of this clinical feasibility study in people with PD is to evaluate the feasibility and potential efficacy of home-based gamified AR gait-and-balance exercises with Cue X. Secondary objectives of this study are to validate the gait-modifying effects of Cue X AR cueing and to quantify the test-retest reliability and concurrent validity of (clinical) outcome measures of gait and balance, as derived from AR headset data.

With these primary and secondary objectives, the study will give insight into 1) the feasibility and potential efficacy of Cue X for home-based gamified AR gait-and-balance exercises, 2) the most effective type of AR cueing and 3) the best parameters for feedback, reporting and sample-size calculations for a subsequent effect study with Cue X. Furthermore, the study will inform about the best AR headset for these purposes.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study consists of four visits to the gait laboratory and four contact moments by telephone divided over 13 weeks. In between visits 1 and 2 (period of 6 weeks), participants do not receive any training or instructions and will carry out their activities as normal. In between laboratory visits 2 and 4, participants will use Cue X to train their gait and balance with gamified AR gait-and-balance exercises in their own home environment as intervention above usual care (6 weeks for a minimum of 30 minutes per day and 5 days a week to comply with World Health Organization \[2020\] movement guidelines). Two different state-of-the-art AR headsets will be used for Cue X training, namely Microsoft's HoloLens 2 and Magic Leap's 2 headsets, randomized over participants using covariate adaptive randomization with age, gender and disease duration as covariates. Half of the participants will train with HoloLens 2 and the other half with Magic Leap 2.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cue X

All participants will train with Cue X gamified AR gait-and-balance-exercises in their home environment for 6 weeks. Participants are invited to use Cue X minimally 5 times a week for 30 minutes total, but preferably on a daily basis. The exact exercises, exercise duration and difficulty level will be prescribed by a movement expert and will be evaluated and adjusted every week in telephone calls or during one of the laboratory assessment.

Half of the participants will train with HoloLens 2 and the other half with Magic Leap 2.

Group Type EXPERIMENTAL

Cue X

Intervention Type DEVICE

The Cue X movement training module includes several games that can be performed in someone's home environment. The games are designed based on known physiotherapy guidelines and evidence for improving motor symptoms for people with PD and delivered in AR. Some of the games also have integrated cueing to allow people with more severe mobility impairments to participate. Feedback of performance can be given using the movement data of the AR headsets.

Interventions

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Cue X

The Cue X movement training module includes several games that can be performed in someone's home environment. The games are designed based on known physiotherapy guidelines and evidence for improving motor symptoms for people with PD and delivered in AR. Some of the games also have integrated cueing to allow people with more severe mobility impairments to participate. Feedback of performance can be given using the movement data of the AR headsets.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have command of the Dutch language
* Diagnosed with PD according to the UK PD Brain Bank criteria (stages 2-4 on the Hoehn and Yahr scale)
* Bothersome gait or balance impairments (i.e., negatively affecting their ability to perform their usual daily activities)

Exclusion Criteria

* Inability to comply with the protocol, i.e. additional neurological diseases and/or orthopaedic problems seriously interfering with gait function, insufficient physical capacity or cognitive/communicative inability (as observed by the researcher or clinician) to understand instructions and participate in the tests
* Visual or hearing impairments (after corrective aids)
* Severe visual hallucinations or illusions
* Inability to walk independently for 30 minutes
* No stable dosage of medication

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No