Freezing of GaitNCT07386015
Etiology-Phenotype-Outcome Pathway Study on Freezing of Gait (FOG)
An observational study of Freezing of Gait and Parkinson's Disease, run by Tianjin Huanhu Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Freezing of Gait, Parkinson's Disease, Parkinsonism
- What is being tested?
- Observational Data Collection
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2026to 30 Nov 2030
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, 300350
Peipei Liu, MD, 86-13512204476, pddoctorpipi2021@163.com
About this study
Official title: FREEZE-Path Cohort: Etiology-Phenotype-Outcome Pathway Study on Freezing of Gait (FOG)
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.
Read the detailed 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.
- Conditions
- Freezing of Gait, Parkinson's Disease, Parkinsonism, Vascular Parkinsonism, Idiopathic Normal Pressure Hydrocephalus (INPH)
- Being tested
- Observational Data Collection
- Keywords
- Freezing of Gait, Parkinson's Disease, parkinsonism
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Data CollectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Observational Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 36 months
Secondary outcomes (8)
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.
Measured: Baseline to 36 months
Frequency of Falls
Number of falls reported during follow-up, collected through clinical visits and follow-up assessments.
Measured: Baseline to 36 months
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.
Measured: Baseline to 36 months
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.
Measured: Baseline to 36 months
Change in Stride Length
Stride length will be assessed during standardized gait tasks using an objective gait assessment system.
The outcome is defined as the change in stride length (meters, m) from baseline to 36 months, with higher values indicating better gait performance.
Measured: Baseline to 36 months
Change in Gait Variability
Gait variability will be quantified during standardized gait tasks using an objective gait assessment system.
Gait variability will be expressed as the coefficient of variation (%) of stride length.
The outcome is defined as the change in gait variability from baseline to 36 months, with lower values indicating better gait stability.
Measured: Baseline to 36 months
Change in Balance Performance Measured by the Mini-Balance Evaluation Systems Test (Mini-BESTest)
Balance performance will be assessed using the Mini-Balance Evaluation Systems Test (Mini-BESTest), a validated clinical scale for evaluating dynamic balance in patients with Parkinson's disease.
The Mini-BESTest total score ranges from 0 to 28, with higher scores indicating better balance performance.
The outcome is defined as the change in Mini-BESTest total score from baseline to 36 months.
Measured: Baseline to 36 months
Changes in functional brain network connectivity assessed by resting-state functional MRI (fMRI)
This outcome evaluates longitudinal changes in fMRI-derived functional connectivity within and between frontal cortical regions, basal ganglia, and brainstem locomotor control areas. The objective is to construct an integrated "brain network-clinical phenotype-FOG outcome" framework, enabling identification of neural network signatures specifically associated with freezing of gait and its progression.
Measured: Baseline to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start28 Feb 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Freezing of GaitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Tianjin Huanhu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peipei Liu, Tianjin Huanhu Hospital
- Investigators
- Peipei Liu, MD, Principal investigator, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386015
- Sponsor's protocol ID
- (Jin Huan) 2025-297
- Status last verified
- Mar 2026
- First submitted
- 24 Dec 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FREEZE-Path Cohort: Etiology-Phenotype-Outcome Pathway Study on Freezing of Gait (FOG)
- ClinicalTrials.gov ID
- NCT07386015
- Acronym / sponsor ID
- (Jin Huan) 2025-297
- Conditions
- Freezing of Gait, Parkinson's Disease, Parkinsonism, Vascular Parkinsonism, Idiopathic Normal Pressure Hydrocephalus (INPH)
- Keywords
- Freezing of Gait, Parkinson's Disease, parkinsonism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Tianjin Huanhu HospitalUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOG Group | – | Other: Observational Data CollectionThis 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. |
| High-Risk Group | – | Other: Observational Data CollectionThis 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. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Data CollectionThis 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. | Other | FOG Group, High-Risk Group |
Primary outcome
Change in Freezing of Gait Severity Measured by the New Freezing of Gait Questionnaire (NFOG-Q)
Time frame: 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.
8 secondary outcomes
Time to First Freezing of Gait Event
Time frame: Baseline to 36 months
Frequency of Falls
Time frame: Baseline to 36 months
Change in Health-Related Quality of Life Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39)
Time frame: Baseline to 36 months
Change in Gait Speed
Time frame: Baseline to 36 months
Change in Stride Length
Time frame: Baseline to 36 months
Change in Gait Variability
Time frame: Baseline to 36 months
Change in Balance Performance Measured by the Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time frame: Baseline to 36 months
Changes in functional brain network connectivity assessed by resting-state functional MRI (fMRI)
Time frame: Baseline to 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background1.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.
- Individual participant dataSharing planned: Undecided
Related trials for Freezing of Gait
Recruiting
Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
Parkinson Disease, Freezing of Gait
Not yet recruiting
Function-based Accelerated Stimulation Therapy (FAST-therapy) for Freezing of Gait (FOG) After Parkinson's Disease (PD)
Parkinson Disease
Active, not recruitingPhase 2
Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
Freezing of Gait, Parkinson Disease
RecruitingObservational study
Visuomotor Control in Parkinson Disease
Parkinson Disease
Recruiting
Correlation of STN-DBS Induced Visuospatial Changes and Freezing of Gait
Parkinson Disease, Gait Disorders, Neurologic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peipei Liu, MD principal investigator
Tianjin Huanhu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Freezing of Gait and Parkinson's Disease, run by Tianjin Huanhu Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peipei Liu, MD (86-13512204476, pddoctorpipi2021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Freezing of Gait Severity Measured by the New Freezing of Gait Questionnaire (NFOG-Q) (time frame: Baseline to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07386015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.