Freezing of Gait - Clinical Outcomes Assessment

Recruiting

• Conditions: PD - Parkinson's Disease
• Interventions: Device: Opals

• Registration Number: NCT06519279
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-25
• Study Start: 2024-10-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Freezing Of Gait Patients	Opals	15 patients with Parkinson disease with freezing of gait (group) in ON \& OFF states
Non Freezing Of Gait Patients	Opals	5 patients with Parkinson disease without freezing of gait (cohort) in ON \& OFF states

Primary Outcome Measures

Name	Time	Method
Validate the newly-developed ClinRO	12/2025	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.

Secondary Outcome Measures

Name	Time	Method
Asses the importance of the FOG symptom for patients	12/2025	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.

Trial Locations

Locations (1)

Tel Aviv Saurasky Medical Center; 🇮🇱 Tel aviv, Israel