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

VU University of Amsterdam

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Cue X

Study type: Interventional

Funder types: Other

Identifiers

NCT05605249

NL82441.100.22

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Cue X

Experimental group

Description:

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.

Treatment:

Device: Cue X