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RECRUITING
NCT06519279

Freezing of Gait - Clinical Outcomes Assessment

Sponsor: Tel-Aviv Sourasky Medical Center

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2024-10-01

Completion Date

2025-12

Last Updated

2025-01-28

Healthy Volunteers

No

Interventions

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.

Locations (1)

Tel Aviv Saurasky Medical Center

Tel Aviv, Israel