Assessing outcomes for freezing of gait in Parkinson's disease
An International Multimodal Protocol for Assessing Freezing of Gait in Individuals Living with Parkinson's Disease
This study is trying to find better ways to measure how bad freezing of gait is for people with Parkinson's disease who can walk on their own.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Locations | 1 site (Tel Aviv) |
| Trial ID | NCT06519279 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop reliable clinician-reported and patient-reported outcome measures to quantify the severity of freezing of gait (FOG) in patients with Parkinson's disease. It will involve patients diagnosed with idiopathic Parkinson's disease who can walk independently and have stable treatment. The study will utilize specific interventions to gather data on FOG severity, which will help in creating standardized assessment tools for clinicians and researchers.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with idiopathic Parkinson's disease who experience freezing of gait and can walk independently.
Not a fit: Patients who have recently experienced significant cardiovascular events or have unstable medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a standardized method for assessing freezing of gait, leading to improved management and treatment strategies for patients with Parkinson's disease.
How similar studies have performed: Other studies have shown success in developing outcome measures for Parkinson's disease, indicating that this approach has potential for meaningful advancements.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tel Aviv
- Tel Aviv Saurasky Medical Center — Tel Aviv, Israel (Recruiting)
Study contacts
- Study coordinator: Omri Batori, B.sc
- Email: omrib@tlvmc.gov.il
- Phone: +972546670256
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.