Status:
RECRUITING
Freezing of Gait - Clinical Outcomes Assessment
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborating Sponsors:
KU Leuven
Oregon Health and Science University
Conditions:
PD - Parkinson's Disease
Eligibility:
All Genders
18+ years
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 quanti...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06519279
Start Date
October 1 2024
End Date
December 1 2025
Last Update
January 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tel Aviv Saurasky Medical Center
Tel Aviv, Israel