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

Primary Purpose

Parkinson Disease, Gait Disorders, Neurologic, Parkinsonian Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No Cue
Conventional Cue
Constant Cue
Patient hand-triggered
Patient eye-triggered
Examiner-triggered
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, Freezing of gait, FOG, PD, augmented reality, cue, cueing, visual, gait freezing

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic FoundationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Augmented-Reality Visual Cues

Arm Description

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.

Outcomes

Primary Outcome Measures

Stride Time Coefficient of Variation
Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Percent Time Freezing
Marker of gait freezing, derived from video recordings of gait performance, and body-worn wireless sensors.

Secondary Outcome Measures

Step Cadence
Marker of dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Gait Velocity
Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Mean Stride Length
Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Total Distance Walked
Marker of gait dysfunction, derived from augmented-reality headset and other body-worn wireless sensors
Freezing Index
Marker of gait freezing, derived from kinematic recordings from body-worn wireless sensors.
Number of Freeze Episodes
Marker of gait freezing, derived from video recordings of gait performance, and body-worn wireless sensors.

Full Information

First Posted
October 31, 2022
Last Updated
December 12, 2022
Sponsor
The Cleveland Clinic
Collaborators
American Parkinson's Disease Association, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05608915
Brief Title
External vs Internal-triggered Augmented-reality Visual Cues to Treat Freezing of Gait
Acronym
ELIMINATE-FOG
Official Title
External vs Internal-triggered Augmented-reality Visual Cues to Treat Freezing of Gait
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
American Parkinson's Disease Association, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Augmented-Reality Visual Cues
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
No Cue
Intervention Description
There will be no visual cues at all. Will be tested off-medication (after holding morning dopaminergic medications).
Intervention Type
Other
Intervention Name(s)
Conventional Cue
Intervention Description
Physical lines taped to floor at regular intervals. Will be tested off-medication (after holding morning dopaminergic medications).
Intervention Type
Other
Intervention Name(s)
Constant Cue
Intervention Description
The augmented-reality visual cue will always be turned on. Will be tested off-medication (after holding morning dopaminergic medications).
Intervention Type
Other
Intervention Name(s)
Patient hand-triggered
Intervention Description
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
Intervention Name(s)
Patient eye-triggered
Intervention Description
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
Intervention Name(s)
Examiner-triggered
Intervention Description
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).
Primary Outcome Measure Information:
Title
Stride Time Coefficient of Variation
Description
Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Time Frame
For each arm, during the single-day research visit only.
Title
Percent Time Freezing
Description
Marker of gait freezing, derived from video recordings of gait performance, and body-worn wireless sensors.
Time Frame
For each arm, during the single-day research visit only.
Secondary Outcome Measure Information:
Title
Step Cadence
Description
Marker of dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Time Frame
For each arm, during the single-day research visit only.
Title
Gait Velocity
Description
Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Time Frame
For each arm, during the single-day research visit only.
Title
Mean Stride Length
Description
Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Time Frame
For each arm, during the single-day research visit only.
Title
Total Distance Walked
Description
Marker of gait dysfunction, derived from augmented-reality headset and other body-worn wireless sensors
Time Frame
For each arm, during the single-day research visit only.
Title
Freezing Index
Description
Marker of gait freezing, derived from kinematic recordings from body-worn wireless sensors.
Time Frame
For each arm, during the single-day research visit only.
Title
Number of Freeze Episodes
Description
Marker of gait freezing, derived from video recordings of gait performance, and body-worn wireless sensors.
Time Frame
For each arm, during the single-day research visit only.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Liao, MD PhD
Phone
216-445-3862
Email
liaoj2@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Liao, MD PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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