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Completed

NCT Number: NCT05605249

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vrije Universiteit Amsterdam

Amsterdam, North Holland, 1081 BT, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. System Usability Scale (SUS) [Usability]

    Time frame: After 6-week training

    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.

  2. Number of adverse events [safety]

    Time frame: During 6-week training

    To measure safety of the Cue X training module

  3. Side effects as reported by participants [safety]

    Time frame: During 6-week training

    To measure safety of the Cue X training module

  4. Adherence to the training programme

    Time frame: During 6-week training

    Actual exercise time as a percentage of prescribed exercise time. The prescribed exercise time is 30 minutes, 5 days a week.

  5. Patient-reported outcome measures (PROMs)

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

    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.

  6. Patient-reported experience measures (PREMs)

    Time frame: After 6-week training

    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.

  7. Mini Balance Evaluation Systems Test (Mini-BESTest) [Gait-and-balance outcome measures]

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

    To measure balance and postural control. Minimum - maximum score: 0 - 28. Higher scores indicate better balance and postural control.

  8. Timed Up-and-Go test (TUG) [Gait-and-balance outcome measures]

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

    To measure functional gait. Higher scores indicate worse functional gait.

  9. Lindop Parkinson's Physiotherapy Assessment Scale (LPPAS) [Gait-and-balance outcome measures]

    Time frame: Change between pre-, mid- and post-training measure (over 12 weeks, which includes 6 weeks waiting list and 6-week intervention)

    To measure gait mobility. Higher scores indicate better gait mobility. Minimum - maximum score: 0 - 18

  10. Targeted walking-related fall-risk assessment as measured by the Interactive Walkway

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

    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)

Secondary outcomes

  1. Five Times Sit to Stand Test (FTSTS)

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

    To measure lower extremity strength [standard clinical tests and questionnaires]. Higher scores indicate worse lower extremity strength.

  2. New Freezing of Gait Questionnaire (NFOGQ)

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

    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.

  3. Movement Disorders Society Unified Parkinson Disease Rating Scale (UPDRS)

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

    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.

  4. Activities-Specific Balance Confidence Scale (ABC)

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

    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.

  5. Falls Efficacy Scale International (FES-I)

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

    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.

  6. Physical Activity Scale for the Elderly (PASE)

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

    To measure physical activity [standard clinical tests and questionnaires]. Higher scores indicate greater physical activity.

  7. Gait speed [Gait-modifying ability and data quality]

    Time frame: Change between pre-, mid- and post-training measure (over 12 weeks, which includes 6 weeks waiting list and 6-week intervention)

    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

  8. Cadence [Gait-modifying ability and data quality]

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

    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

  9. Step length [Gait-modifying ability and data quality]

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

    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

  10. Step time [Gait-modifying ability and data quality]

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

    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

Sponsors and collaborators

Lead sponsor

VU University of Amsterdam

Other

Collaborators

  • Strolll, Ltd

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2022
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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