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OpenTrials
Completed

NCT Number: NCT05608915

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Cue

Other

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

Conventional Cue

Other

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

Constant Cue

Other

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

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).

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).

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).

Primary outcomes

  1. Stride Time Coefficient of Variation

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

    Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.

  2. Percent Time Freezing

    Time frame: 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 outcomes

  1. Step Cadence

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

    Marker of dysfunction, derived from kinematic recordings from body-worn wireless sensors.

  2. Gait Velocity

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

    Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.

  3. Mean Stride Length

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

    Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.

  4. Total Distance Walked

    Time frame: 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

  5. Freezing Index

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

    Marker of gait freezing, derived from kinematic recordings from body-worn wireless sensors.

  6. Number of Freeze Episodes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • American Parkinson's Disease Association, Inc

Registry information

Acronym: ELIMINATE-FOG

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2022
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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