External vs Internal-triggered Augmented-reality Visual Cues to Treat Freezing of Gait (ELIMINATE-FOG)

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Parkinsonian Disorders; Movement Disorders; Gait Disorders, Neurologic; Gait, Unsteady; Gait, Festinating
• Intervention / Treatment: Other: No Cue; Other: Conventional Cue; Other: Constant Cue; Other: Patient hand-triggered; Other: Patient eye-triggered; Other: Examiner-triggered

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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).

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: American Parkinson's Disease Association, Inc
• Investigators: Principal Investigator: James Liao, MD PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2022
• Primary Completion (Actual): July 28, 2023
• Study Completion (Actual): July 28, 2023

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: augmented reality; Parkinson disease; Freezing of gait; PD; FOG; cue; cueing; visual; gait freezing
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Basal Ganglia Diseases; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Nervous System Diseases; Movement Disorders; Parkinsonian Disorders; Gait Disorders, Neurologic
• Other Study ID Numbers: 22-846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: At time of publication, a point of contact individual on the study team will be identified. Third parties will be able to request access to de-identified data used to support the publication findings by application to the Cleveland Clinic IRB. A data use agreement will be put in place between the CCF Cleveland Clinic and this third party for approved use of the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No