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

Parkinson Disease Clinical Trial

— ELIMINATE-FOG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05608915
• Other study ID #: 22-846
• Status: Completed
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: July 28, 2023

Study information

• Verified date: December 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 28, 2023
• Est. primary completion date: July 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Festinating
• Gait, Unsteady
• Movement Disorders
• Nervous System Diseases
• Parkinson Disease
• Parkinsonian Disorders

Intervention

Other:
• No Cue
There will be no visual cues at all. Will be tested off-medication (after holding morning dopaminergic medications).
• Conventional Cue
Physical lines taped to floor at regular intervals. Will be tested off-medication (after holding morning dopaminergic medications).
• Constant Cue
The augmented-reality visual cue will always be turned on. Will be tested off-medication (after holding morning dopaminergic medications).
• 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).
• 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).
• 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).

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	American Parkinson's Disease Association, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Step Cadence	Marker of dysfunction, derived from kinematic recordings from body-worn wireless sensors.	For each arm, during the single-day research visit only.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.