External vs Internal-triggered Augmented-reality Visual Cues to Treat Freezing of Gait
- Conditions
- Parkinson DiseaseParkinsonian DisordersGait Disorders, NeurologicMovement DisordersGait, UnsteadyGait, Festinating
- Interventions
- Other: No CueOther: Conventional CueOther: Constant CueOther: Patient hand-triggeredOther: Patient eye-triggeredOther: Examiner-triggered
- Registration Number
- NCT05608915
- Lead Sponsor
- The Cleveland Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Augmented-Reality Visual Cues Patient hand-triggered 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. Augmented-Reality Visual Cues No Cue 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. Augmented-Reality Visual Cues Conventional Cue 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. Augmented-Reality Visual Cues Examiner-triggered 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. Augmented-Reality Visual Cues Constant Cue 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. Augmented-Reality Visual Cues Patient eye-triggered 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.
- Primary Outcome Measures
Name Time Method Stride Time Coefficient of Variation For each arm, during the single-day research visit only. Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Percent Time Freezing For each arm, during the single-day research visit only. Marker of gait freezing, derived from video recordings of gait performance, and body-worn wireless sensors.
- Secondary Outcome Measures
Name Time Method Freezing Index For each arm, during the single-day research visit only. Marker of gait freezing, derived from kinematic recordings from body-worn wireless sensors.
Gait Velocity For each arm, during the single-day research visit only. Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Mean Stride Length For each arm, during the single-day research visit only. Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Total Distance Walked For each arm, during the single-day research visit only. Marker of gait dysfunction, derived from augmented-reality headset and other body-worn wireless sensors
Step Cadence For each arm, during the single-day research visit only. Marker of dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Number of Freeze Episodes For each arm, during the single-day research visit only. Marker of gait freezing, derived from video recordings of gait performance, and body-worn wireless sensors.
Trial Locations
- Locations (1)
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States