NCT06519279招募中不适用
An International Multimodal Protocol for Assessing Freezing of Gait in Individuals Living with Parkinson's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Validate the newly-developed ClinRO
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Validate the newly-developed ClinRO
时间窗: 12/2025
Rate scale of freezing of gait to detect meaningful improvement in freezing of gait. The scale name is " Freezing Of Gait Severity Score". it consist a 8 trials, each one can be rate between 0 to 8. the scale consist a part of frequency of the freezing and part of cumulative duration. The higher the score, the more severe the stagnation and the lower it is, the less stagnation is present.
次要结局
- Asses the importance of the FOG symptom for patients(12/2025)
研究者
研究点 (1)
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