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

NCT ID: NCT05608915

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-17

Study Completion Date

2023-07-28

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.

Detailed Description

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Conditions

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

Keywords

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Parkinson disease Freezing of gait FOG PD augmented reality cue cueing visual gait freezing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Augmented-Reality Visual Cues

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.

Group Type EXPERIMENTAL

No Cue

Intervention Type OTHER

There will be no visual cues at all. Will be tested off-medication (after holding morning dopaminergic medications).

Conventional Cue

Intervention Type OTHER

Physical lines taped to floor at regular intervals. Will be tested off-medication (after holding morning dopaminergic medications).

Constant Cue

Intervention Type OTHER

The augmented-reality visual cue will always be turned on. Will be tested off-medication (after holding morning dopaminergic medications).

Patient hand-triggered

Intervention Type OTHER

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).

Patient eye-triggered

Intervention Type OTHER

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).

Examiner-triggered

Intervention Type OTHER

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).

Interventions

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No Cue

There will be no visual cues at all. Will be tested off-medication (after holding morning dopaminergic medications).

Intervention Type OTHER

Conventional Cue

Physical lines taped to floor at regular intervals. Will be tested off-medication (after holding morning dopaminergic medications).

Intervention Type OTHER

Constant Cue

The augmented-reality visual cue will always be turned on. Will be tested off-medication (after holding morning dopaminergic medications).

Intervention Type 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).

Intervention Type 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).

Intervention Type 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).

Intervention Type OTHER

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Parkinson's Disease Association, Inc

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Liao, MD PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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22-846

Identifier Type: -

Identifier Source: org_study_id