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Freezing of Gait - Clinical Outcomes Assessment

Freezing of Gait - Clinical Outcomes Assessment

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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 neurological (than PD) or orthopaedic impairment that significantly impacts on gait.
  2. Unwilling to temporarily delay the morning anti-Parkinsonian medication.
  3. Preganacy and

Study details
    PD - Parkinson's Disease

NCT06519279

Tel-Aviv Sourasky Medical Center

16 October 2025

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