Actively Recruiting

Age: 18Years +
All Genders
ID06519279

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

Led by Tel-Aviv Sourasky Medical Center · Updated on 2025-01-28

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

T

Tel-Aviv Sourasky Medical Center

Lead Sponsor

K

KU Leuven

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are working to develop reliable and accurate measures that doctors and patients can use to assess the severity of Freezing of Gait (FOG) in individuals with Parkinson's Disease. This study focuses on creating both clinician-reported and patient-reported outcome tools to better quantify FOG symptoms. These tools aim to help clinicians and researchers understand FOG more precisely and improve evaluation methods. Participants include groups of Parkinson's patients with and without freezing of gait. Patients with FOG will be monitored using sensors called Opals placed on their shins, feet, and lower back. Additionally, those with FOG will wear an Axivity monitor on their lower back continuously for seven days to track mobility. The study observes participants in both ON and OFF medication states to capture detailed gait data. During the study, participants will undergo assessments in controlled sessions while wearing the sensors. The Axivity device collects continuous movement data over a week, even during sleep and showering, as it is waterproof. Researchers will validate the new clinician-reported outcome tool by the end of 2025 and assess how important the FOG symptom is to patients. Total participation time varies based on individual assessments and monitoring periods.

CONDITIONS

Brief Title

Freezing of Gait - Clinical Outcomes Assessment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of idiopathic Parkinson's disease by a neurologist according to Movement Disorders Society guidelines
  • Able to walk independently for at least 10 meters without a walking aid
  • No Deep Brain Stimulator implanted
  • Stable Parkinson's disease treatment for at least 4 weeks prior to participation, with no expected changes during the study
  • For patients with Freezing of Gait, a score of 1 or higher on the New Freezing of Gait Questionnaire (NFOG-Q)
Not Eligible

You will not qualify if you...

  • History within 3 months prior to consent of myocardial infarction, unstable angina hospitalization, stroke, coronary artery bypass graft, percutaneous coronary intervention, cardiac resynchronization therapy device implantation, active cancer treatment, uncontrolled congestive heart disease (NYHA class >3), acute psychosis, major psychiatric disorders, substance abuse, or other neurological or orthopedic conditions significantly affecting gait
  • Unwillingness to temporarily delay morning anti-Parkinsonian medication
  • Pregnancy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 session and 7 days of continuous monitoring

Participants are fitted with wearable sensors to monitor freezing of gait symptoms and mobility.

1 in-person session plus continuous sensor wear for 7 days

Long-term Monitoring

Duration - Up to study completion in December 2025

Participants' mobility data are collected over time to assess freezing of gait symptoms and validate clinical outcomes.

Follow-up assessments as scheduled by the study team

Trial Site Locations

Total: 1 location

1

Tel Aviv Saurasky Medical Center

Tel Aviv, Israel

Actively Recruiting

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Research Team

O

Omri Batori, B.sc

J

Jeffery Hausdorff, Professor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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