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NCT05608915 · ClinicalTrials.gov registry record · NA
External vs Internal-triggered Augmented-reality Visual Cues to Treat Freezing of Gait
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 36
- Enrollment target
NCT05608915 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 36 participants.
The verdict
NCT05608915, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
Study 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.
Interventions
- OTHER No Cue
- OTHER Conventional Cue
- OTHER Constant Cue
- OTHER Patient hand-triggered
- OTHER Patient eye-triggered
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-11-17 |
| Est. Completion | 2023-07-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05608915
The ClinicalTrials.gov registry entry for NCT05608915 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which No Cue is the first listed.
NCT05608915 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05608915 about?
NCT05608915 is a clinical study titled "External vs Internal-triggered Augmented-reality Visual Cues to Treat Freezing of Gait". 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, ...
What is the current status of trial NCT05608915?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2022-11-17. Estimated completion is 2023-07-28.
What interventions are being tested in trial NCT05608915?
The interventions under investigation include: No Cue (OTHER), Conventional Cue (OTHER), Constant Cue (OTHER), Patient hand-triggered (OTHER), Patient eye-triggered (OTHER).
Who is sponsoring clinical trial NCT05608915?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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