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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Cue X


Participation Criteria
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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 (Severe) visual or hearing impairments (after corrective aids) (Severe) visual hallucinations or illusions Inability to walk independently for 30 minutes No stable dosage of medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cue X<br>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. | Device: Cue X<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Usability Scale (SUS) [Usability] | A 10-item questionnaire to measure usability of the Cue X training module, answered on a 5 point Likert scale (1 strongly disagree - 5 strongly agree). Minimum - maximum score: 10 - 50. Higher scores imply better usability of the Cue X software. | After 6-week training | 
| Number of adverse events [safety] | To measure safety of the Cue X training module | During 6-week training | 
| Side effects as reported by participants [safety] | To measure safety of the Cue X training module | During 6-week training | 
| Adherence to the training programme | Actual exercise time as a percentage of prescribed exercise time. The prescribed exercise time is 30 minutes, 5 days a week. | During 6-week training | 
| Patient-reported outcome measures (PROMs) | An example is quality of life as measured by the Parkinson's Disease Questionnaire (PDQ-39). This questionnaire assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living, among which quality of life. Higher scores on one of the dimensions indicate worse well-being on that specific dimension. | Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention) | 
| Patient-reported experience measures (PREMs) | Perceived effectiveness of the Cue X training programme through Likert scale reporting and semi-structured interview questions during weekly phone calls and a post-intervention interview. | After 6-week training | 
| Mini Balance Evaluation Systems Test (Mini-BESTest) [Gait-and-balance outcome measures] | To measure balance and postural control. Minimum - maximum score: 0 - 28. Higher scores indicate better balance and postural control. | Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention) | 
| Timed Up-and-Go test (TUG) [Gait-and-balance outcome measures] | To measure functional gait. Higher scores indicate worse functional gait. | Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention) | 
| Lindop Parkinson's Physiotherapy Assessment Scale (LPPAS) [Gait-and-balance outcome measures] | To measure gait mobility. Higher scores indicate better gait mobility. Minimum - maximum score: 0 - 18 | Change between pre-, mid- and post-training measure (over 12 weeks, which includes 6 weeks waiting list and 6-week intervention) | 
| Targeted walking-related fall-risk assessment as measured by the Interactive Walkway | Targeted walking-related fall-risk assessment based on outcome measures of walking adaptability as determined with the Interactive Walkway (obstacle avoidance margins and success rates and stepping accuracy and walking speed during goal-directed stepping) | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Five Times Sit to Stand Test (FTSTS) | To measure lower extremity strength [standard clinical tests and questionnaires]. Higher scores indicate worse lower extremity strength. | Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention) | 
| New Freezing of Gait Questionnaire (NFOGQ) | To measure freezing of gait severity [standard clinical tests and questionnaires]. Higher scores indicate the severity and the burden of freezing of gait in daily life is worse. Minimum - maximum score: 0 - 28. | Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention) | 
| Movement Disorders Society Unified Parkinson Disease Rating Scale (UPDRS) | To measure overall PD severity [standard clinical tests and questionnaires]. The UPDRS consists of three segments: I) Mentation, Behavior and Mood, II) Activities of Daily Living, and III) Motor Examination. Higher scores on these segments and higher total scores indicate more severe PD symptoms. | Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention) | 
| Activities-Specific Balance Confidence Scale (ABC) | To measure balance confidence [standard clinical tests and questionnaires]. Minimum - maximum score: 0 - 1600. Higher scores indicate more confidence in performing daily activities without losing balance. | Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention) | 
| Falls Efficacy Scale International (FES-I) | To measure fear of falling [standard clinical tests and questionnaires]. Minimum - maximum score: 16 - 64. Higher scores indicate that the participant is more concerned about falling. | Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention) | 
| Physical Activity Scale for the Elderly (PASE) | To measure physical activity [standard clinical tests and questionnaires]. Higher scores indicate greater physical activity. | Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention) | 
| Gait speed [Gait-modifying ability and data quality] | Spatiotemporal gait parameters (speed, cadence, step length, step time) derived from Interactive Walkway and AR headsets during the 8-meter walking test (with or without visual/auditory cues) and standard clinical tests of gait and balance derived from AR headsets and stopwatch scores | Change between pre-, mid- and post-training measure (over 12 weeks, which includes 6 weeks waiting list and 6-week intervention) | 
| Cadence [Gait-modifying ability and data quality] | Spatiotemporal gait parameters (speed, cadence, step length, step time) derived from Interactive Walkway and AR headsets during the 8-meter walking test (with or without visual/auditory cues) and standard clinical tests of gait and balance derived from AR headsets and stopwatch scores | Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention) | 
| Step length [Gait-modifying ability and data quality] | Spatiotemporal gait parameters (speed, cadence, step length, step time) derived from Interactive Walkway and AR headsets during the 8-meter walking test (with or without visual/auditory cues) and standard clinical tests of gait and balance derived from AR headsets and stopwatch scores | Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention) | 
| Step time [Gait-modifying ability and data quality] | Spatiotemporal gait parameters (speed, cadence, step length, step time) derived from Interactive Walkway and AR headsets during the 8-meter walking test (with or without visual/auditory cues) and standard clinical tests of gait and balance derived from AR headsets and stopwatch scores | Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cue X, Augmented reality, Gait and balance exercise program, Clinical feasibility study