RecruitingNCT06519279

Freezing of Gait - Clinical Outcomes Assessment

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

Sponsor

Tel-Aviv Sourasky Medical Center

Enrollment

20 participants

Start Date

Oct 1, 2024

Study Type

OBSERVATIONAL

Conditions

PD - Parkinson's Disease

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting information about freezing of gait — a symptom of Parkinson's disease where a person suddenly feels like their feet are glued to the floor — to better understand and measure it. **You may be eligible if...** - You have been diagnosed with Parkinson's disease by a neurologist - You can walk at least 10 meters on your own without a walking aid - Your Parkinson's medications have been stable for the past 4 weeks - If you have freezing episodes, they have been confirmed by a questionnaire **You may NOT be eligible if...** - You have a deep brain stimulator - You have had a heart attack, stroke, or major cardiac procedure in the past 3 months - You have another neurological or bone/joint problem that significantly affects how you walk - You are unwilling to briefly delay your morning Parkinson's medication for testing - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOpals

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

DEVICEAxivity

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.

Locations(1)

Tel Aviv Saurasky Medical Center

Tel Aviv, Israel

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NCT06519279

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