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NCT Number: NCT06519279

Freezing of Gait - Clinical Outcomes Assessment

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).

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Key information

Conditions

PD - Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Opals

Device

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

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.

Primary outcomes

  1. Validate the newly-developed ClinRO

    Time frame: 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 outcomes

  1. Asses the importance of the FOG symptom for patients

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeffery Hausdorff, Professor

CONTACT

[email protected]

Omri Batori, B.sc

CONTACT

[email protected]

+972546670256

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Collaborators

  • Emory University
  • KU Leuven
  • Oregon Health and Science University
  • Radbound University Medical Center
  • University of Rochester
  • University of Sydney
  • University of Waterloo

Registry information

Official study title

An International Multimodal Protocol for Assessing Freezing of Gait in Individuals Living with Parkinson's Disease

Acronym: FOG-COA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2024
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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