Clinical trial NCT05608915: External vs Internal-triggered Augmented-reality Visual Cues to Treat Freezing of Gait
Official title: External vs Internal-triggered Augmented-reality Visual Cues to Treat Freezing of Gait
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: American Parkinson's Disease Association, Inc
First posted: 2022-11-08
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Stride Time Coefficient of Variation
timeFrame: For each arm, during the single-day research visit only.
measure: Percent Time Freezing
timeFrame: For each arm, during the single-day research visit only.
Secondary outcomes:
measure: Step Cadence
timeFrame: For each arm, during the single-day research visit only.
measure: Gait Velocity
timeFrame: For each arm, during the single-day research visit only.
measure: Mean Stride Length
timeFrame: For each arm, during the single-day research visit only.
measure: Total Distance Walked
timeFrame: For each arm, during the single-day research visit only.
measure: Freezing Index
timeFrame: For each arm, during the single-day research visit only.
measure: Number of Freeze Episodes
timeFrame: For each arm, during the single-day research visit only.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: James Liao, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: