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Freezing of Gait - Clinical Outcomes Assessment

NCT06519279 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-01-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • University of Sydney

    collaborator OTHER

  • Radbound University Medical Center

    collaborator UNKNOWN

  • University of Waterloo

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • University of Rochester

    collaborator OTHER

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06519279 on ClinicalTrials.gov