NCT05608915

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	No Cue	There will be no visual cues at all. Will be tested off-medication (after holding morning dopaminergic medications).
OTHER	Conventional Cue	Physical lines taped to floor at regular intervals. Will be tested off-medication (after holding morning dopaminergic medications).
OTHER	Constant Cue	The augmented-reality visual cue will always be turned on. Will be tested off-medication (after holding morning dopaminergic medications).
OTHER	Patient hand-triggered	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).
OTHER	Patient eye-triggered	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).
OTHER	Examiner-triggered	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).

Timeline

• Start date: 2022-11-17
• Primary completion: 2023-07-28
• Completion: 2023-07-28
• First posted: 2022-11-08
• Last updated: 2023-12-18

Locations

1 site across 1 country: United States