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Recruiting NCT06519279

Freezing of Gait - Clinical Outcomes Assessment

Trial Parameters

Condition PD - Parkinson's Disease
Sponsor Tel-Aviv Sourasky Medical Center
Study Type OBSERVATIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-10-01
Completion 2025-12
Interventions
OpalsAxivity

Brief 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).

Eligibility Criteria

Inclusion Criteria: 1. Diagnosis of idiopathic Parkinson's disease (PD) made by a neurologist according to the Movement Disorders Society guidelines; 2. Able to walk independently for a distance of 10 meters, without walking aid; 3. Absence of a Deep Brain Stimulator; 4. Stable PD treatment in the 4 weeks prior to participation that is not expected to change in the course of the study. 5. For patients with FOG: a score of ≥ 1 on the New Freezing Of Gait Questionnaire (NFOG-Q). Exclusion Criteria: 1. 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 neurolog

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