Freezing of Gait - Clinical Outcomes Assessment

N/ARecruitingNCT06519279

Tel-Aviv Sourasky Medical Center20 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

PD - Parkinson's Disease

Interventions

OpalsDEVICE

Five Oplas sensors were strategically placed on participants: one on each shin, one on each foot, and one on the lower back.

AxivityDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of idiopathic Parkinson's disease (PD) made by a neurologist according to the Movement Disorders Society guidelines; 2. Able to walk independently for a distance of 10 meters, without walking aid; 3. Absence of a Deep Brain Stimulator; 4. Stable PD treatment in the 4 weeks prior to participation that is not expected to change in the course of the study. 5. For patients with FOG: a score of ≥ 1 on the New Freezing Of Gait Questionnaire (NFOG-Q). Exclusion Criteria: 1. 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. 2. Unwilling to temporarily delay the morning anti-Parkinsonian medication. 3. Preganacy and

Locations (1)

Tel Aviv Saurasky Medical Center

Tel Aviv, Israel

RECRUITING

Outcomes

Primary Outcomes

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: 12/2025

Secondary Outcomes

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: 12/2025

Central Contacts

Omri Batori, B.sc

CONTACT

+972546670256 omrib@tlvmc.gov.il

Jeffery Hausdorff, Professor

CONTACT

jeffh@tlvmc.gov.il

Data from ClinicalTrials.gov

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