Parkinson DiseaseNCT05605249
Remotely Prescribed and Monitored Home-based Gait-and-balance Augmented Reality Exergaming for People With Parkinson's Disease.
A study testing Cue X in people with Parkinson Disease, run by VU University of Amsterdam at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Cue X
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Dec 2022to 5 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Vrije Universiteit Amsterdam
Amsterdam, North Holland, 1081 BT
About this study
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
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Cue X
- Keywords
- Cue X, Augmented reality, Gait and balance exercise program, Clinical feasibility study
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cue XDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cue X |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 6-week training
Number of adverse events [safety]
To measure safety of the Cue X training module
Measured: During 6-week training
Side effects as reported by participants [safety]
To measure safety of the Cue X training module
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
To measure lower extremity strength [standard clinical tests and questionnaires]. Higher scores indicate worse lower extremity strength.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start13 Dec 2022
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- Strolll, Ltd
- Responsible party
- Principal investigator, dr. Daphne J. Geerse, VU University of Amsterdam
- Investigators
- Melvyn Roerdink, PhD, Study director, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605249
- Sponsor's protocol ID
- NL82441.100.22
- Status last verified
- Aug 2024
- First submitted
- 30 Sep 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is part of a collaboration between the Vrije Universiteit Amsterdam and Strolll, the manufacturer of Cue X. Movement- and/or environmental data from the headsets and gold standards and information on adherence (e.g., tasks performed, hours spend on games) of this study will be shared anonymously with Strolll to be used for the further development of Cue X. Anonymized research data will be published along with articles as supplemental material or will be made available in a repository.
Publications
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.
PubMed 38539250Hardeman 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.
PubMed 38872812
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05605249
- Acronym / sponsor ID
- NL82441.100.22
- Conditions
- Parkinson Disease
- Keywords
- Cue X, Augmented reality, Gait and balance exercise program, Clinical feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Collaborators
- Strolll, Ltd
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cue X | Experimental | Device: Cue XAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cue XThe 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. | Device | Cue X |
Primary outcome
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.
Number of adverse events [safety]
Time frame: During 6-week training
To measure safety of the Cue X training module
Side effects as reported by participants [safety]
Time frame: During 6-week training
To measure safety of the Cue X training module
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.
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.
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.
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.
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.
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
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)
10 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 38539250Hardeman 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.
- Background: PubMed 38872812Hardeman 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.
- Individual participant dataSharing planned: No. This study is part of a collaboration between the Vrije Universiteit Amsterdam and Strolll, the manufacturer of Cue X. Movement- and/or environmental data from the headsets and gold standards and information on adherence (e.g., tasks performed, hours spend on games) of this study will be shared anonymously with Strolll to be used for the further development of Cue X. Anonymized research data will be published along with articles as supplemental material or will be made available in a repository.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melvyn Roerdink, PhD study director
VU University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cue X in people with Parkinson Disease, run by VU University of Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (SUS) [Usability] (time frame: After 6-week training). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05605249, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.