Clinical trial NCT05605249: Remotely Prescribed and Monitored Home-based Gait-and-balance Augmented Reality Exergaming for People With Parkinson's Disease.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Cue X
Augmented reality
Gait and balance exercise program
Clinical feasibility study
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
Collaborators: name: Strolll, Ltd
First posted: 2022-11-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: System Usability Scale (SUS) [Usability]
timeFrame: After 6-week training
measure: Number of adverse events [safety]
timeFrame: During 6-week training
measure: Side effects as reported by participants [safety]
timeFrame: During 6-week training
measure: Adherence to the training programme
timeFrame: During 6-week training
measure: Patient-reported outcome measures (PROMs)
timeFrame: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
measure: Patient-reported experience measures (PREMs)
timeFrame: After 6-week training
measure: Mini Balance Evaluation Systems Test (Mini-BESTest) [Gait-and-balance outcome measures]
timeFrame: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
measure: Timed Up-and-Go test (TUG) [Gait-and-balance outcome measures]
timeFrame: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
measure: Lindop Parkinson's Physiotherapy Assessment Scale (LPPAS) [Gait-and-balance outcome measures]
timeFrame: Change between pre-, mid- and post-training measure (over 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
measure: Targeted walking-related fall-risk assessment as measured by the Interactive Walkway
timeFrame: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Secondary outcomes:
measure: Five Times Sit to Stand Test (FTSTS)
timeFrame: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
measure: New Freezing of Gait Questionnaire (NFOGQ)
timeFrame: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
measure: Movement Disorders Society Unified Parkinson Disease Rating Scale (UPDRS)
timeFrame: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
measure: Activities-Specific Balance Confidence Scale (ABC)
timeFrame: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
measure: Falls Efficacy Scale International (FES-I)
timeFrame: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
measure: Physical Activity Scale for the Elderly (PASE)
timeFrame: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
measure: Gait speed [Gait-modifying ability and data quality]
timeFrame: Change between pre-, mid- and post-training measure (over 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
measure: Cadence [Gait-modifying ability and data quality]
timeFrame: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
measure: Step length [Gait-modifying ability and data quality]
timeFrame: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
measure: Step time [Gait-modifying ability and data quality]
timeFrame: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Amsterdam
state: Noord-Holland
Study officials:
affiliation: VU University of Amsterdam
name: Melvyn Roerdink, PhD
role: STUDY_DIRECTOR
References:
citation: Hardeman LES, Geerse DJ, Hoogendoorn EM, Nonnekes J, Roerdink M. 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. Pilot Feasibility Stud. 2024 Mar 27;10(1):54. doi: 10.1186/s40814-024-01480-w.
citation: Hardeman LES, Geerse DJ, Hoogendoorn EM, Nonnekes J, Roerdink M. 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. Front Neurol. 2024 May 30;15:1373740. doi: 10.3389/fneur.2024.1373740. eCollection 2024.