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

NCT05605249 | Completed

• 1 other identifier: NL82441.100.22
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Cue X; Augmented reality; Gait and balance exercise program; Clinical feasibility study

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (10)

• Five Times Sit to Stand Test (FTSTS)

  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)

  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)

  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)

  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)

  Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)

Study Arms (1)

Cue X

EXPERIMENTAL

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

Interventions

Cue X 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.

Cue X

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VU University of Amsterdam: lead
• Strolll, Ltd: collaborator

Study Sites (1)

Vrije Universiteit Amsterdam

Amsterdam, North Holland, 1081 BT, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 38539250 BACKGROUND

• 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.

  PMID: 38872812 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Melvyn Roerdink, PhD

  VU University of Amsterdam

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: November 4, 2022
• Study Start: December 13, 2022
• Primary Completion: July 5, 2023
• Study Completion: July 5, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)