Etiology-Phenotype-Outcome Pathway Study on Freezing of Gait (FOG)

Tianjin Huanhu Hospital

Status: Begins enrollment this month

Conditions: Vascular Parkinsonism; Freezing of Gait; Idiopathic Normal Pressure Hydrocephalus (INPH); Parkinson's Disease; Parkinsonism

Treatments: Other: Observational Data Collection

Study type: Observational

Funder types: Other

Identifiers

NCT07386015

(Jin Huan) 2025-297

Details and patient eligibility

About

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.

Full description

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.

The primary objectives of this registry are to:

Characterize the longitudinal course and clinical variability of freezing of gait; Examine associations between freezing of gait, gait and balance impairment, falls, and clinical outcomes; Identify potential clinical phenotypes and risk factors associated with worsening gait dysfunction and adverse outcomes.

The findings from this registry are intended to support hypothesis generation, improve clinical risk assessment, and provide a foundation for the development of future mechanistic studies and interventional trials targeting freezing of gait and related gait disorders.

Enrollment: 700 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 30-85 years
2. Presence of freezing of gait or non-freezing gait or balance impairment
3. 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)
4. Ability to complete gait and balance assessment tasks independently or with assistance
5. Ability and willingness to provide written informed consent

Exclusion criteria

1. Severe dementia (Mini-Mental State Examination score < 10)
2. Severe psychiatric disorders interfering with study participation
3. Severe cardiopulmonary, musculoskeletal, or other medical conditions significantly affecting gait safety
4. Stroke, fracture, or other major medical events within the past 3 months
5. Inability to comply with follow-up procedures
6. Refusal of video or speech data collection

Trial design

700 participants in 2 patient groups

FOG Group

Description:

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.

Treatment:

Other: Observational Data Collection

High-Risk Group

Description:

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.

Treatment:

Other: Observational Data Collection