NCT06519279

Freezing of Gait - Clinical Outcomes Assessment

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Opals	Five Oplas sensors were strategically placed on participants: one on each shin, one on each foot, and one on the lower back.
DEVICE	Axivity	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.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-07-25
• Last updated: 2025-01-28

Locations

1 site across 1 country: Israel