An observational study in PD - Parkinson's Disease, sponsored by Tel-Aviv Sourasky Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by Tel-Aviv Sourasky Medical Center · Observational
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).
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 20 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.
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FOG \& NON-DOG
Exclusion Criteria:
15 patients with Parkinson disease with freezing of gait (group) in ON \& OFF states
Device: Opals · Device: Axivity
5 patients with Parkinson disease without freezing of gait (cohort) in ON \& OFF states
Device: Opals · Device: Axivity
Five Oplas sensors were strategically placed on participants: one on each shin, one on each foot, and one on the lower back.
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.
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.
Time frame: 12/2025
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.
Time frame: 12/2025
Plan to share: Undecided
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Tel-Aviv Sourasky Medical Center