Freezing of Gait - Clinical Outcomes Assessment

NCT ID: NCT06519279

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Freezing Of Gait Patients

15 patients with Parkinson disease with freezing of gait (group) in ON \& OFF states

Opals

Intervention Type: DEVICE

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

Axivity

Intervention Type: DEVICE

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.

Non Freezing Of Gait Patients

5 patients with Parkinson disease without freezing of gait (cohort) in ON \& OFF states

Opals

Intervention Type: DEVICE

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

Axivity

Intervention Type: DEVICE

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.

Interventions

Opals

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of idiopathic Parkinson's disease (PD) made by a neurologist according to the Movement Disorders Society guidelines;

2. Able to walk independently for a distance of 10 meters, without walking aid;

3. Absence of a Deep Brain Stimulator;

4. Stable PD treatment in the 4 weeks prior to participation that is not expected to change in the course of the study.

5. For patients with FOG: a score of ≥ 1 on the New Freezing Of Gait Questionnaire (NFOG-Q).

Exclusion Criteria

1. Occurrence of any of the following within 3 months prior to informed consent: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy device (CRTD), active treatment for cancer or other malignant disease, uncontrolled congestive heart disease (NYHA class >3), acute psychosis or major psychiatric disorders or continued substance abuse, other neurological (than PD) or orthopaedic impairment that significantly impacts on gait.

2. Unwilling to temporarily delay the morning anti-Parkinsonian medication.

3. Preganacy and

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: collaborator

Radbound University Medical Center

UNKNOWN

Sponsor Role: collaborator

University of Waterloo

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tel Aviv Saurasky Medical Center

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Omri Batori, B.sc

Role: CONTACT

omrib@tlvmc.gov.il

+972546670256

Jeffery Hausdorff, Professor

Role: CONTACT

jeffh@tlvmc.gov.il

Facility Contacts

omri Batori, B.sc

Role: primary

omrib@tlvmc.gov.il

+972546670256

Shahar Siman Toc, B.sc

Role: backup

shaharst@tlvmc.gov.il

+972526736689

Jeffery Hausdorff, Proffesor

Role: backup

Other Identifiers

0608-23-TLV

Identifier Type: -

Identifier Source: org_study_id