Parkinson DiseaseELIMINATE-FOGNCT05608915
External vs Internal-triggered Augmented-reality Visual Cues to Treat Freezing of Gait
A study testing No Cue, Conventional Cue and Constant Cue in people with Parkinson Disease and Gait Disorders, Neurologic, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Parkinson Disease, Gait Disorders, Neurologic, Parkinsonian Disorders
- What is being tested?
- No Cue, Conventional Cue and Constant Cue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2022to 28 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic, Parkinsonian Disorders, Movement Disorders, Gait, Unsteady, Gait, Festinating
- Being tested
- No Cue, Conventional Cue, Constant Cue, Patient hand-triggered, Patient eye-triggered
- Keywords
- Parkinson disease, Freezing of gait, FOG, PD, augmented reality, cue, cueing, visual, gait freezing
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic, Parkinsonian Disorders, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No CueOther
There will be no visual cues at all. Will be tested off-medication (after holding morning dopaminergic medications).
Conventional CueOther
Physical lines taped to floor at regular intervals. Will be tested off-medication (after holding morning dopaminergic medications).
Constant CueOther
The augmented-reality visual cue will always be turned on. Will be tested off-medication (after holding morning dopaminergic medications).
Patient hand-triggeredOther
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-triggeredOther
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-triggeredOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Augmented-Reality Visual Cues | Experimental | 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. Receives: Other: No Cue; Other: Conventional Cue; Other: Constant Cue; Other: Patient hand-triggered; Other: Patient eye-triggered; Other: Examiner-triggered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride Time Coefficient of Variation
Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Measured: For each arm, during the single-day research visit only.
Percent Time Freezing
Marker of gait freezing, derived from video recordings of gait performance, and body-worn wireless sensors.
Measured: For each arm, during the single-day research visit only.
Secondary outcomes (6)
Step Cadence
Marker of dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Measured: For each arm, during the single-day research visit only.
Gait Velocity
Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Measured: For each arm, during the single-day research visit only.
Mean Stride Length
Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Measured: For each arm, during the single-day research visit only.
Total Distance Walked
Marker of gait dysfunction, derived from augmented-reality headset and other body-worn wireless sensors
Measured: For each arm, during the single-day research visit only.
Freezing Index
Marker of gait freezing, derived from kinematic recordings from body-worn wireless sensors.
Measured: For each arm, during the single-day research visit only.
Number of Freeze Episodes
Marker of gait freezing, derived from video recordings of gait performance, and body-worn wireless sensors.
Measured: For each arm, during the single-day research visit only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start17 Nov 2022
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- American Parkinson's Disease Association, Inc
- Responsible party
- Sponsor
- Investigators
- James Liao, MD PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608915
- Sponsor's protocol ID
- 22-846
- Acronym
- ELIMINATE-FOG
- Status last verified
- Dec 2023
- First submitted
- 31 Oct 2022
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External vs Internal-triggered Augmented-reality Visual Cues to Treat Freezing of Gait
- ClinicalTrials.gov ID
- NCT05608915
- Acronym / sponsor ID
- ELIMINATE-FOG / 22-846
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- American Parkinson's Disease Association, Inc
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Augmented-Reality Visual Cues | Experimental | Other: No Cue, Other: Conventional Cue, Other: Constant Cue, Other: Patient hand-triggered, Other: Patient eye-triggered, Other: Examiner-triggeredIn 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No CueThere will be no visual cues at all. Will be tested off-medication (after holding morning dopaminergic medications). | Other | Augmented-Reality Visual Cues |
| Conventional CuePhysical lines taped to floor at regular intervals. Will be tested off-medication (after holding morning dopaminergic medications). | Other | Augmented-Reality Visual Cues |
| Constant CueThe augmented-reality visual cue will always be turned on. Will be tested off-medication (after holding morning dopaminergic medications). | Other | Augmented-Reality Visual Cues |
| Patient hand-triggeredThe 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). | Other | Augmented-Reality Visual Cues |
| Patient eye-triggeredThe 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). | Other | Augmented-Reality Visual Cues |
| Examiner-triggeredThe 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). | Other | Augmented-Reality Visual Cues |
Primary outcome
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.
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.
6 secondary outcomes
Step Cadence
Time frame: For each arm, during the single-day research visit only.
Gait Velocity
Time frame: For each arm, during the single-day research visit only.
Mean Stride Length
Time frame: For each arm, during the single-day research visit only.
Total Distance Walked
Time frame: For each arm, during the single-day research visit only.
Freezing Index
Time frame: For each arm, during the single-day research visit only.
Number of Freeze Episodes
Time frame: For each arm, during the single-day research visit only.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Parkinson Disease
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Enrolling by invitation
Efficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease
Parkinson's Disease, Depression
RecruitingPhase 1/2
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Liao, MD PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Cue, Conventional Cue and Constant Cue in people with Parkinson Disease and Gait Disorders, Neurologic, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stride Time Coefficient of Variation (time frame: For each arm, during the single-day research visit only.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.