NCT05718739

Assessing and Understanding Freezing of Gait at Home: FOG@Home

Assessing and Understanding Freezing of Gait At-home Environment: FOG@Home

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 35 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Freezing of gait, (FOG) is an unpredictable, abrupt, short phenomenon that severely affects Parkinson's disease (PD) patients' gait and quality of life. The common measure tools are self-questioners that present the subjective feelings and the FOG provoking tests that used in clinic for evoking FOG and getting the estimated duration and the phenotype of the expressed phenomenon. The objective of this study is to investigate the FOG phenomenon using video cameras at patients' home with combination of wearable-axivity sensors and smart soles with a goal of objective assessment and quantification of freezing of gait severity in unsupervised daily-living environment of the PD patients.

Detailed description

30 PD subjects, referred by the Movement Disorders Centre would be enrolled in the study according to eligibility criteria. By prior arrangement, the researchers will arrive to the participant's home. After explanation and consent process, the participant would sign the consent form. At that point, the patient would be assessed, before the execution of the experimental protocol. Hoehn and Yahr staging (H\&Y), Unified Parkinson's Disease Rating Scale (UPDRS) and common cognitive tests would be applied. Then, the participant would be ask to put the motion sensors (accelerometers) and place the cameras in strategic places in the house, where he expect to see most freezing of gait events while walking around the house (no bedrooms and bathrooms). After activating the systems, the researchers would go, leaving the video system and the sensors for 7 days (depending on the amount of received data) in the patient house.

Conditions

• Parkinson Disease
• Freezing of Gait

Interventions

Type	Name	Description
DEVICE	AX6 6-axis logging accelerometer	The device is collecting longitudinal movement data.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-05-01
• Completion: 2024-12-01
• First posted: 2023-02-08
• Last updated: 2023-02-08

Locations

1 site across 1 country: Israel