NCT05605249

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

Completed NA Last updated 21 August 2024

What this trial tests

NA trial testing Cue X in Parkinson Disease in 24 participants. Completed in 5 July 2023.

Timeline

13 December 2022

Primary endpoint
5 July 2023

5 July 2023

Quick facts

Lead sponsor	VU University of Amsterdam
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	13 December 2022
Primary completion	5 July 2023
Estimated completion	5 July 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• Cue X

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

VU University of Amsterdam

Who can join

18 and older, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Remotely prescribed and monitored home-based gait-and-balance therapeutic exergaming using augmented reality (AR) glasses: protocol for a clinical feasibility study in people with Parkinson's disease.
   Hardeman LES, Geerse DJ, Hoogendoorn EM, Nonnekes J, et al · · 2024 · cited 10× · PMID 38539250 · DOI 10.1186/s40814-024-01480-w
2. 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.
   Hardeman LES, Geerse DJ, Hoogendoorn EM, Nonnekes J, et al · · 2024 · cited 9× · PMID 38872812 · DOI 10.3389/fneur.2024.1373740
3. Remotely prescribed and monitored home-based gait-and-balance therapeutic exergaming using augmented reality (AR) glasses: protocol for a clinical feasibility study in people with Parkinson’s disease
   Hardeman L, Geerse D, Hoogendoorn E, Nonnekes J, et al · · 2023 · DOI 10.21203/rs.3.rs-3035368/v1