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
This trial does not accept healthy volunteersQualifiers
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 population
FOG \& NON-DOG
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Opals
DeviceFive Oplas sensors were strategically placed on participants: one on each shin, one on each foot, and one on the lower back.
Axivity
DeviceAt the end of the first session, participants with FOG, will be fitted with an Axivity monitor. This is wearable sensor that will be attached to the participant's lower back (lumbar vertebrae 4-5) with hypoallergic medical tape by the researcher, and will be worn continuously for seven days. The Axivity monitor is a small (23 x 32.5 x 8.9 mm) and lightweight (11g) device that measures mobility via a tri-axial accelerometer and gyroscope and stores this data onboard, no GPS or other localization options are possible with this monitor. Participants will be given following guidelines concerning the use: The sensor is to be worn continuously during the seven-day period, i.e. also while sleeping and showering. The sensor is waterproof and can be worn during showering.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Freezing Of Gait Patients2 interventions
Group B: Non Freezing Of Gait Patients2 interventions
Trial outcomes
Primary outcomes
1
Validate the newly-developed ClinRO
Rate scale of freezing of gait to detect meaningful improvement in freezing of gait. The scale name is " Freezing Of Gait Severity Score". it consist a 8 trials, each one can be rate between 0 to 8. the scale consist a part of frequency of the freezing and part of cumulative duration. The higher the score, the more severe the stagnation and the lower it is, the less stagnation is present.
Time frame
12/2025Secondary outcomes
1
Asses the importance of the FOG symptom for patients
Severity of freezing of gait (FOG) symptoms and patient-reported impact on quality of life. The scale name is " Freezing Of Gait Severity Score". it consist a 8 trials, each one can be rate between 0 to 8. the scale consist a part of frequency of the freezing and part of cumulative duration. The higher the score, the more severe the stagnation and the lower it is, the less stagnation is present.
Time frame
12/2025Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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