External vs Internal-triggered Augmented-reality Visual Cues to Treat Freezing of Gait

Study Overview
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Brief Summary
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Postural instability, freezing-of-gait (FOG), and falls are among the greatest unmet needs in Parkinson disease (PD). FOG eventually affects more than half of people with PD, and is notoriously difficult to treat pharmacologically or via deep brain stimulation. Visual cues do improve gait freezing, but their efficacy and adoption is limited because they are not practical to use in all real-world situations. There is a need for a cueing technique that is on-demand and discreet - only perceptible to the patient. Fortunately, recent technological advances in augmented-reality (AR) enable such an approach. In this study, state-of-the-art AR glasses will be used to project digital cues that are only visible to the wearer, to determine if they can improve FOG. 36 individuals with PD and FOG will be recruited to perform an obstacle-course gait task under six cue conditions: no cue, conventional cue, constant-on AR, patient-hand-triggered AR (turns on when patient clicks button), patient-eye-triggered AR (turns on when looking down), and examiner-triggered AR. The AR cue is a set of images that appear on the floor at a patient's feet, mimicking floor lines. Gait performance will be captured on video and via body-worn wireless sensors that detect how each limb is moving. The investigators will determine whether individuals are cue-able with conventional visual cues, whether intermittent cues outperform constant-on cues, and whether cues triggered by an examiner outperform cues triggered by patients themselves.

Official Title
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External vs Internal-triggered Augmented-reality Visual Cues to Treat Freezing of Gait

Conditions
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Parkinson Disease, Gait Disorders, Neurologic, Parkinsonian Disorders, Movement Disorders, Gait, Unsteady, Gait, Festinating

Intervention / Treatment
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* Other: No Cue
* Other: Conventional Cue
* Other: Constant Cue
* Other: Patient hand-triggered
* Other: Patient eye-triggered
* Other: Examiner-triggered


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of PD Presence of freezing of gait, defined as a score of ≥1 in MDS-UPDRS 2.13, or 3.11. Can walk without assistance, OFF meds, based on yes/no verbal response Exclusion Criteria: Severity of gait impairment should not require dependency to walker or cane Concomitant conditions that may affect significantly the evaluation of balance or gait, including orthopedic, rheumatologic or other neurological diseases Contraindication to physical therapy Severe bilateral visual impairment Age < 21 Diagnosis of dementia Not agreeable to having video taken of entire research visit

Ages Eligible for Study
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Minimum Age: 21 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: All participants will receive all interventions in a crossover fashion, on the same day. All participants will first experience the conventional cue intervention. The order of the remaining interventions will be randomized. All conditions will be performed after participants hold (do not take) their morning dopaminergic medications.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Augmented-Reality Visual Cues<br>In this single-arm study, all participants will receive all interventions on the same day. They will be wearing an augmented-reality headset that will display a digital obstacle course. Walking performance will be captured with no visual cues, with conventional visual cues, and with augmented-reality visual cues. | Other: No Cue<br>* There will be no visual cues at all. Will be tested off-medication (after holding morning dopaminergic medications).<br>Other: Conventional Cue<br>* Physical lines taped to floor at regular intervals. Will be tested off-medication (after holding morning dopaminergic medications).<br>Other: Constant Cue<br>* The augmented-reality visual cue will always be turned on. Will be tested off-medication (after holding morning dopaminergic medications).<br>Other: Patient hand-triggered<br>* The augmented-reality visual cue will be turned on, intermittently, each time the patient clicks a handheld button. Will be tested off-medication (after holding morning dopaminergic medications).<br>Other: Patient eye-triggered<br>* The augmented-reality visual cue will be turned on, intermittently, each time the patient looks down at the floor near their feet. Will be tested off-medication (after holding morning dopaminergic medications).<br>Other: Examiner-triggered<br>* The augmented-reality visual cue will be turned on, intermittently, by an examiner, whenever they feel the patient is having a freezing episode or at risk of having a freezing episode. Will be tested off-medication (after holding morning dopaminergic medications).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stride Time Coefficient of Variation | Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors. | For each arm, during the single-day research visit only. | 
| Percent Time Freezing | Marker of gait freezing, derived from video recordings of gait performance, and body-worn wireless sensors. | For each arm, during the single-day research visit only. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step Cadence | Marker of dysfunction, derived from kinematic recordings from body-worn wireless sensors. | For each arm, during the single-day research visit only. | 
| Gait Velocity | Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors. | For each arm, during the single-day research visit only. | 
| Mean Stride Length | Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors. | For each arm, during the single-day research visit only. | 
| Total Distance Walked | Marker of gait dysfunction, derived from augmented-reality headset and other body-worn wireless sensors | For each arm, during the single-day research visit only. | 
| Freezing Index | Marker of gait freezing, derived from kinematic recordings from body-worn wireless sensors. | For each arm, during the single-day research visit only. | 
| Number of Freeze Episodes | Marker of gait freezing, derived from video recordings of gait performance, and body-worn wireless sensors. | For each arm, during the single-day research visit only. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson disease, Freezing of gait, FOG, PD, augmented reality, cue, cueing, visual, gait freezing