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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-85
SponsorTianjin Huanhu Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational Data Collection

    Other intervention

    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.

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: FOG Group1 intervention
Group B: High-Risk Group1 intervention

Trial outcomes

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.

Time frame
Baseline to 36 months

Secondary outcomes

1

Time to First Freezing of Gait Event

Time from baseline to the first occurrence of freezing of gait in participants without freezing of gait at baseline.

Time frame
Baseline to 36 months
2

Frequency of Falls

Number of falls reported during follow-up, collected through clinical visits and follow-up assessments.

Time frame
Baseline to 36 months
3

Change in Health-Related Quality of Life Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39)

Health-related quality of life will be assessed using the Parkinson's Disease Questionnaire-39 (PDQ-39), a validated patient-reported outcome measure for individuals with Parkinson's disease. The PDQ-39 Summary Index score ranges from 0 to 100, with higher scores indicating worse health-related quality of life. The outcome is defined as the change in PDQ-39 Summary Index score from baseline to 36 months.

Time frame
Baseline to 36 months
4

Change in Gait Speed

Gait speed will be measured during standardized gait tasks using an objective gait assessment system. The outcome is defined as the change in gait speed (meters per second, m/s) from baseline to 36 months, with higher values indicating better gait performance.

Time frame
Baseline to 36 months

Other outcomes

Sponsors and contacts

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