Freezing of Gait - Clinical Outcomes Assessment
Recruiting · NCT06519279 · Observational (researchers observe without assigning treatment) · Lead sponsor: Tel-Aviv Sourasky Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
AxivityOpals
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Tel Aviv Saurasky Medical Center - Tel Aviv, Israel