Freezing of Gait - Clinical Outcomes Assessment
ConditionPD - Parkinson's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTel-Aviv Sourasky Medical Center
About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Opals
- Axivity
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tel-Aviv Sourasky Medical Center
Lead sponsor
KU Leuven
Collaborator
Oregon Health and Science University
Collaborator
University of Sydney
Collaborator
Radbound University Medical Center
Collaborator
University of Waterloo
Collaborator
Emory University
Collaborator
University of Rochester
Collaborator
Source ClinicalTrials.gov