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

NCT07386015 | Recruiting

• 1 other identifier: (Jin Huan) 2025-297
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Freezing of Gait; Parkinson's Disease; parkinsonism

Outcome Measures

Primary Outcomes (1)

• Change in Freezing of Gait Severity Measured by the New Freezing of Gait Questionnaire (NFOG-Q)

  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.

  Baseline to 36 months

Secondary Outcomes (8)

• 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

Study Arms (2)

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.

Other: Observational Data Collection

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.

Other: Observational Data Collection

Interventions

Observational Data Collection OTHER

This is an observational patient registry. No experimental drugs, devices, or procedures are assigned as part of the study. All participants receive standard medical care, and data are collected during routine clinical visits and follow-up assessments.

FOG Group; High-Risk Group

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adults aged 30 to 85 years with freezing of gait or gait and balance impairment. Participants are diagnosed with Parkinson's disease or other parkinsonian or related neurological disorders associated with freezing of gait, including but not limited to parkinsonian syndromes and other causes of gait dysfunction. Both participants with established freezing of gait and participants at high risk for developing freezing of gait are included. All participants are recruited from neurology and related specialty clinics at participating centers and are followed longitudinally as part of a prospective observational patient registry.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300350, China

RECRUITING

Related Publications (1)

• 1.Talia H, Yael B, Michal B, et al.: A meta-analysis identifies factors predicting the future development of freezing of gait in parkinson's disease[J]. NPJ Parkinsons Dis 2023, 9.10.1038/s41531-023-00600-2. 2.Richard C, Meg E M, Frederico P-F, et al.: Prevention of falls in parkinson's disease: Guidelines and gaps[J]. Mov Disord Clin Pract 2023, 10.10.1002/mdc3.13860. 3.Seira T, Yuta K, Takanori K, et al.: New insights into freezing of gait in parkinson's disease from spectral dynamic causal modeling[J]. Mov Disord 2024, 39.10.1002/mds.29988. 4.Giladi N, Nieuwboer A. Understanding and treating freezing of gait in Parkinson's disease: a review of current concepts and future directions. Lancet Neurology. 2008;7(8):720-730. 5.Kelvin L C, Prabesh K, Miriam vEB, et al.: Cholinergic system changes in dopa-unresponsive freezing of gait in parkinson's disease[J]. Mov Disord 2025, 40.10.1002/mds.30196.

  BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Peipei Liu, MD

  Tianjin Huanhu Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peipei Liu, MD

CONTACT

86-13512204476; pddoctorpipi2021@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: February 4, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): November 30, 2030
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

CN (1)