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

NCT05608915 | Completed

• 1 other identifier: 22-846
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Step Cadence

  For each arm, during the single-day research visit only.

• Gait Velocity

  For each arm, during the single-day research visit only.

• Mean Stride Length

  For each arm, during the single-day research visit only.

• Total Distance Walked

  For each arm, during the single-day research visit only.

• Freezing Index

  For each arm, during the single-day research visit only.

Study Arms (1)

Augmented-Reality Visual Cues

EXPERIMENTAL

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; Other: Conventional Cue; Other: Constant Cue; Other: Patient hand-triggered; Other: Patient eye-triggered; Other: Examiner-triggered

Interventions

No Cue OTHER

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

Augmented-Reality Visual Cues

Conventional Cue OTHER

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

Augmented-Reality Visual Cues

Constant Cue OTHER

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

Augmented-Reality Visual Cues

Patient hand-triggered 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).

Augmented-Reality Visual Cues

Patient eye-triggered 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).

Augmented-Reality Visual Cues

Examiner-triggered 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).

Augmented-Reality Visual Cues

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• American Parkinson's Disease Association, Inc: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic; Parkinsonian Disorders; Movement Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James Liao, MD PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 8, 2022
• Study Start: November 17, 2022
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)