PD - Parkinson's DiseaseFOG-COANCT06519279
Freezing of Gait - Clinical Outcomes Assessment
An observational study of PD - Parkinson's Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
To develop a reliable and accurate clinician-reported outcome (ClinRO) measure (against a new and precise definition) and patient reported outcome (PRO) for use by clinicians and researchers to quantify the severity of Freezing of Gait (FOG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PD - Parkinson's Disease
- What is being tested?
- Opals and Axivity
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2024to Dec 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: FOG \& NON-DOG
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease (PD) made by a neurologist according to the Movement Disorders Society guidelines;
- Able to walk independently for a distance of 10 meters, without walking aid;
- Absence of a Deep Brain Stimulator;
- Stable PD treatment in the 4 weeks prior to participation that is not expected to change in the course of the study.
- For patients with FOG: a score of ≥ 1 on the New Freezing Of Gait Questionnaire (NFOG-Q).
Who cannot join
- Occurrence of any of the following within 3 months prior to informed consent: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy device (CRTD), active treatment for cancer or other malignant disease, uncontrolled congestive heart disease (NYHA class >3), acute psychosis or major psychiatric disorders or continued substance abuse, other neurological (than PD) or orthopaedic impairment that significantly impacts on gait.
- Unwilling to temporarily delay the morning anti-Parkinsonian medication.
- Preganacy and
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jeffery Hausdorff, Professor contact
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Saurasky Medical Center
Tel Aviv
omri Batori, B.sc, +972546670256, omrib@tlvmc.gov.il
Shahar Siman Toc, B.sc, +972526736689, shaharst@tlvmc.gov.il
About this study
Official title: An International Multimodal Protocol for Assessing Freezing of Gait in Individuals Living with Parkinson's Disease
To develop a reliable and accurate clinician-reported outcome (ClinRO) measure (against a new and precise definition) and patient reported outcome (PRO) for use by clinicians and researchers to quantify the severity of Freezing of Gait (FOG).
- Conditions
- PD - Parkinson's Disease
- Being tested
- Opals, Axivity
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpalsDevice
Five Oplas sensors were strategically placed on participants: one on each shin, one on each foot, and one on the lower back.
AxivityDevice
At the end of the first session, participants with FOG, will be fitted with an Axivity monitor. This is wearable sensor that will be attached to the participant's lower back (lumbar vertebrae 4-5) with hypoallergic medical tape by the researcher, and will be worn continuously for seven days.
The Axivity monitor is a small (23 x 32.5 x 8.9 mm) and lightweight (11g) device that measures mobility via a tri-axial accelerometer and gyroscope and stores this data onboard, no GPS or other localization options are possible with this monitor. Participants will be given following guidelines concerning the use:
The sensor is to be worn continuously during the seven-day period, i.e. also while sleeping and showering.
The sensor is waterproof and can be worn during showering.
| Study group | Role | What they receive |
|---|---|---|
| Freezing Of Gait Patients | 15 patients with Parkinson disease with freezing of gait (group) in ON \& OFF states Receives: Device: Opals; Device: Axivity | |
| Non Freezing Of Gait Patients | 5 patients with Parkinson disease without freezing of gait (cohort) in ON \& OFF states Receives: Device: Opals; Device: Axivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the newly-developed ClinRO
Rate scale of freezing of gait to detect meaningful improvement in freezing of gait. The scale name is " Freezing Of Gait Severity Score". it consist a 8 trials, each one can be rate between 0 to 8. the scale consist a part of frequency of the freezing and part of cumulative duration. The higher the score, the more severe the stagnation and the lower it is, the less stagnation is present.
Measured: 12/2025
Secondary outcomes (1)
Asses the importance of the FOG symptom for patients
Severity of freezing of gait (FOG) symptoms and patient-reported impact on quality of life. The scale name is " Freezing Of Gait Severity Score". it consist a 8 trials, each one can be rate between 0 to 8. the scale consist a part of frequency of the freezing and part of cumulative duration. The higher the score, the more severe the stagnation and the lower it is, the less stagnation is present.
Measured: 12/2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Oct 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PD - Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- KU Leuven, Oregon Health and Science University, University of Sydney, Radboud University Medical Center, University of Waterloo, Emory University, University of Rochester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519279
- Sponsor's protocol ID
- 0608-23-TLV
- Acronym
- FOG-COA
- Status last verified
- Jan 2025
- First submitted
- 3 Jul 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Multimodal Protocol for Assessing Freezing of Gait in Individuals Living with Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06519279
- Acronym / sponsor ID
- FOG-COA / 0608-23-TLV
- Conditions
- PD - Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- KU Leuven, Oregon Health and Science University, University of Sydney, Radboud University Medical Center, University of Waterloo, Emory University, University of Rochester
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Jul 2024 (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.
To develop a reliable and accurate clinician-reported outcome (ClinRO) measure (against a new and precise definition) and patient reported outcome (PRO) for use by clinicians and researchers to quantify the severity of Freezing of Gait (FOG).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freezing Of Gait Patients | – | Device: Opals, Device: Axivity15 patients with Parkinson disease with freezing of gait (group) in ON \& OFF states |
| Non Freezing Of Gait Patients | – | Device: Opals, Device: Axivity5 patients with Parkinson disease without freezing of gait (cohort) in ON \& OFF states |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- FOG \& NON-DOG
Key inclusion criteria (5 listed)
- Diagnosis of idiopathic Parkinson's disease (PD) made by a neurologist according to the Movement Disorders Society guidelines;
- Able to walk independently for a distance of 10 meters, without walking aid;
- Absence of a Deep Brain Stimulator;
- Stable PD treatment in the 4 weeks prior to participation that is not expected to change in the course of the study.
- For patients with FOG: a score of ≥ 1 on the New Freezing Of Gait Questionnaire (NFOG-Q).
Key exclusion criteria (3 listed)
- Occurrence of any of the following within 3 months prior to informed consent: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy device (CRTD), active treatment for cancer or other malignant disease, uncontrolled congestive heart disease (NYHA class >3), acute psychosis or major psychiatric disorders or continued substance abuse, other neurological (than PD) or orthopaedic impairment that significantly impacts on gait.
- Unwilling to temporarily delay the morning anti-Parkinsonian medication.
- Preganacy and
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 |
|---|---|---|
| OpalsFive Oplas sensors were strategically placed on participants: one on each shin, one on each foot, and one on the lower back. | Device | Freezing Of Gait Patients, Non Freezing Of Gait Patients |
| AxivityAt the end of the first session, participants with FOG, will be fitted with an Axivity monitor. This is wearable sensor that will be attached to the participant's lower back (lumbar vertebrae 4-5) with hypoallergic medical tape by the researcher, and will be worn continuously for seven days. The Axivity monitor is a small (23 x 32.5 x 8.9 mm) and lightweight (11g) device that measures mobility via a tri-axial accelerometer and gyroscope and stores this data onboard, no GPS or other localization options are possible with this monitor. Participants will be given following guidelines concerning the use: The sensor is to be worn continuously during the seven-day period, i.e. also while sleeping and showering. The sensor is waterproof and can be worn during showering. | Device | Freezing Of Gait Patients, Non Freezing Of Gait Patients |
Primary outcome
Validate the newly-developed ClinRO
Time frame: 12/2025
Rate scale of freezing of gait to detect meaningful improvement in freezing of gait. The scale name is " Freezing Of Gait Severity Score". it consist a 8 trials, each one can be rate between 0 to 8. the scale consist a part of frequency of the freezing and part of cumulative duration. The higher the score, the more severe the stagnation and the lower it is, the less stagnation is present.
1 secondary outcome
Asses the importance of the FOG symptom for patients
Time frame: 12/2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jeffery Hausdorff, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PD - Parkinson's Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. 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 Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omri Batori, B.sc (+972546670256, omrib@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate the newly-developed ClinRO (time frame: 12/2025). 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 28 Jan 2025.