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NCT06519279Recruiting

Freezing of Gait - Clinical Outcomes Assessment

An International Multimodal Protocol for Assessing Freezing of Gait in Individuals Living with Parkinson's Disease

Source: ClinicalTrials.gov · Last updated 28 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Observational
Enrollment
20 (estimated)
First submitted
3 Jul 2024
Start date
1 Oct 2024
Primary completion date
Dec 2025
Lead sponsor
Tel-Aviv Sourasky Medical Center
NCT number
NCT06519279

What you commit to

  • Study type: Observational
  • Planned participants: 20
  • From 1 Oct 2024 to the primary completion date, Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other

  • Preganacy and

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tel Aviv Saurasky Medical Center
Coordinator of this site? Confirm its status
Tel AvivIsraelRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.