Freezing of Gait - Clinical Outcomes Assessment

NCT06519279 | Recruiting

• 1 other identifier: 0608-23-TLV
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

PD - Parkinson's Disease

Outcome Measures

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.

  12/2025

Secondary Outcomes (1)

• Asses the importance of the FOG symptom for patients

  12/2025

Study Arms (2)

Freezing Of Gait Patients

15 patients with Parkinson disease with freezing of gait (group) in ON \& OFF states

Device: Opals; Device: Axivity

Non Freezing Of Gait Patients

5 patients with Parkinson disease without freezing of gait (cohort) in ON \& OFF states

Device: Opals; Device: Axivity

Interventions

Opals DEVICE

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

Freezing Of Gait Patients; Non Freezing Of Gait Patients

Axivity DEVICE

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.

Freezing Of Gait Patients; Non Freezing Of Gait Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

FOG \& NON-DOG

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• 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

Study Sites (1)

Tel Aviv Saurasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Omri Batori, B.sc

CONTACT

+972546670256; omrib@tlvmc.gov.il

Jeffery Hausdorff, Professor

CONTACT

jeffh@tlvmc.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 25, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

IL (1)