Freezing of Gait - Clinical Outcomes Assessment
An International Multimodal Protocol for Assessing Freezing of Gait in Individuals Living with Parkinson's Disease
Tel-Aviv Sourasky Medical Center
20 participants
Oct 1, 2024
OBSERVATIONAL
Conditions
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 quantify the severity of Freezing of Gait (FOG).
Eligibility
Inclusion Criteria5
- 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 Criteria3
- 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
Interventions
Five Oplas sensors were strategically placed on participants: one on each shin, one on each foot, and one on the lower back.
At 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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06519279