Recruiting NCT06519279
Freezing of Gait - Clinical Outcomes Assessment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Opals, Axivity.
- Who it may be relevant to
- Registry conditions: PD - Parkinson's Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An International Multimodal Protocol for Assessing Freezing of Gait in Individuals Living with Parkinson's Disease
Overview
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).
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
Primary outcome measures
- Validate the newly-developed ClinRO [Time frame: 12/2025]
Secondary outcome measures (1)
- Asses the importance of the FOG symptom for patients [Time frame: 12/2025]
Eligibility criteria
Inclusion criteria
- Diagnosis of idiopathic Parkinson's disease (PD) made by a neurologist according to the Movement Disorders Society guidelines;
- Able to walk independently for a distance of 10 meters, without walking aid;
- Absence of a Deep Brain Stimulator;
- Stable PD treatment in the 4 weeks prior to participation that is not expected to change in the course of the study.
- For patients with FOG: a score of ≥ 1 on the New Freezing Of Gait Questionnaire (NFOG-Q).
Exclusion criteria
- 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.
- Unwilling to temporarily delay the morning anti-Parkinsonian medication.
- Preganacy and
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Israel · 1 center
- Tel Aviv Saurasky Medical Center — Tel Aviv
Identifiers
NCT: NCT06519279 · 0608-23-TLV