FREEZE-Path Cohort: Etiology-Phenotype-Outcome Pathway Study on Freezing of Gait (FOG)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Change in Freezing of Gait Severity Measured by the New Freezing of Gait Questionnaire (NFOG-Q)
研究概览
简要总结
This study is a prospective, multicenter, observational cohort (patient registry) designed to better understand freezing of gait (FOG), a disabling walking problem that can occur in Parkinson's disease and other related neurological conditions.The purpose of this registry is to collect long-term clinical information from patients with freezing of gait or gait and balance problems, and to explore how different causes of FOG are related to symptoms, walking patterns, falls, disease progression, and outcomes over time. The study will include participants with Parkinson's disease and other conditions associated with freezing of gait.Participants will receive standard medical care as determined by their treating physicians. No experimental drugs or study-related treatments will be assigned as part of this registry. Clinical information will be collected during routine visits and follow-up assessments, including questionnaires, walking and balance evaluations, video recordings, and other commonly used clinical tests.The information collected in this study may help improve the understanding of freezing of gait, support better risk assessment for falls, and guide future research and clinical management strategies for patients with gait and balance disorders.
详细描述
Freezing of gait (FOG) is a common and disabling gait disturbance characterized by a transient inability to initiate or maintain effective stepping. It is most frequently observed in Parkinson's disease but can also occur in other parkinsonian syndromes and neurological conditions associated with gait and balance dysfunction. Freezing of gait is associated with falls, loss of independence, reduced quality of life, and increased caregiver burden, yet its underlying mechanisms, clinical heterogeneity, and long-term trajectories remain incompletely understood.
This study is a prospective, multicenter, observational patient registry designed to systematically collect longitudinal clinical data from adults with freezing of gait, gait and balance impairment, or those at high risk for developing freezing of gait. Participants will be recruited from neurology and related specialty clinics at participating centers and followed over time as part of routine clinical care.
The registry will collect a broad range of clinical information, including but not limited to:
Demographic and clinical characteristics; Freezing of gait severity and related symptoms; Objective gait parameters and balance performance assessed using standardized gait tasks; Motor symptom severity and functional status; Falls and fall-related outcomes; Health-related quality of life and other patient-reported outcomes. Clinical assessments will be performed at baseline and during scheduled follow-up visits over a planned follow-up period of up to 36 months. Data collection may include questionnaires, clinician-rated scales, objective gait and balance assessments, and video-based evaluations, depending on local clinical practice and participant capability.
This registry is non-interventional. All diagnostic and therapeutic decisions, including medication adjustments and rehabilitative interventions, will be made solely by the treating physicians according to standard clinical practice. The study does not mandate any experimental drugs, devices, or procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-85 years
- •Presence of freezing of gait or non-freezing gait or balance impairment
- •Diagnosis of Parkinson's disease or related parkinsonian disorders according to established international criteria (including PD, PSP, MSA, DLB, CBD, vascular parkinsonism, or idiopathic normal pressure hydrocephalus)
- •Ability to complete gait and balance assessment tasks independently or with assistance
- •Ability and willingness to provide written informed consent
排除标准
- •Severe dementia (Mini-Mental State Examination score < 10)
- •Severe psychiatric disorders interfering with study participation
- •Severe cardiopulmonary, musculoskeletal, or other medical conditions significantly affecting gait safety
- •Stroke, fracture, or other major medical events within the past 3 months
- •Inability to comply with follow-up procedures
- •Refusal of video or speech data collection
研究组 & 干预措施
FOG Group
This cohort includes participants with freezing of gait present at baseline. Participants may have Parkinson's disease or other neurological conditions associated with freezing of gait. All participants receive standard clinical care as determined by their treating physicians. No experimental treatments or study-specific interventions are assigned as part of this observational registry.
干预措施: Observational Data Collection (Other)
High-Risk Group
This cohort includes participants with gait or balance impairment who have not developed freezing of gait at baseline but are considered at high risk for future freezing of gait. Participants may have Parkinson's disease or related neurological disorders. All participants receive standard clinical care, and no experimental treatments or study-specific interventions are provided as part of this observational registry.
干预措施: Observational Data Collection (Other)
结局指标
主要结局
Change in Freezing of Gait Severity Measured by the New Freezing of Gait Questionnaire (NFOG-Q)
时间窗: Baseline to 36 months
The New Freezing of Gait Questionnaire (NFOG-Q) is a patient-reported outcome measure assessing the severity and impact of freezing of gait in Parkinson's disease. The total score ranges from 0 to 28, with higher scores indicating more severe freezing of gait. The primary outcome is the change in NFOG-Q total score from baseline to 36 months.
次要结局
- Time to First Freezing of Gait Event(Baseline to 36 months)
- Frequency of Falls(Baseline to 36 months)
- Change in Health-Related Quality of Life Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39)(Baseline to 36 months)
- Change in Gait Speed(Baseline to 36 months)
- Change in Stride Length(Baseline to 36 months)
- Change in Gait Variability(Baseline to 36 months)
- Change in Balance Performance Measured by the Mini-Balance Evaluation Systems Test (Mini-BESTest)(Baseline to 36 months)
- Changes in functional brain network connectivity assessed by resting-state functional MRI (fMRI)(Baseline to 36 months.)
研究者
Peipei Liu
Principal Investigator
Tianjin Huanhu Hospital