NCT07580612 AID-FOG: Artificial Intelligence-Driven Freezing of Gait Detection in the Home
| NCT ID | NCT07580612 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KU Leuven |
| Condition | Parkinson Disease, Idiopathic |
| Study Type | OBSERVATIONAL |
| Enrollment | 126 participants |
| Start Date | 2025-09-22 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 126 participants in total. It began in 2025-09-22 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Freezing of gait (FOG) is a debilitating symptom of Parkinson's disease increases the risk of falling. Despite being a common symptom, it is still difficult to evaluate freezing of gait quickly and accurately. Currently, the gold-standard method to determine the severity of FOG is a manual analysis of video footage by an experienced assessor, collected during standardized FOG-provoking walking tests. Because this is a very time-intensive process, where different assessors sometimes obtain different results, our team at KU Leuven have developed an artificial-intelligent (AI) algorithm trained to identify FOG episodes based on wearable inertial measurement unit (IMU) sensor data. The AI algorithm has already undergone initial validation during laboratory testing, yielding promising results. The aim of this study is to investigate whether the AI algorithm can accurately detect FOG episodes in a less controlled environment, namely the home environment. In a second phase, the investigators will also use the collected data to improve the AI algorithm for automated FOG detection in the home. Finally, the investigators want to explore whether the AI algorithm can detect FOG in real-time.
Eligibility Criteria
Inclusion Criteria: For all participants * Voluntary written informed consent of the participant has been obtained prior to any study-related procedures, except the non-recorded pre-screening questions; * At least 18 years of age at the time of signing the Informed Consent Form (ICF); * Person is cognitively able to follow and understand instructions and provide voluntary written informed consent; * Person is able to walk for short distances (± 10 meters) independently, with- or without use of a walking aid; * Person does not live in a temporary or permanent care facility. For participants with PD: * Clinical diagnosis of Parkinson's disease (PD) made by a neurologist according to the Movement Disorders Society guidelines; * Person self-reports to experience daily FOG (for recruitment of freezers only); * Person is willing to temporarily delay the morning anti-Parkinsonian medication during the standardized assessment visit. Exclusion criteria: * Occurrence of any of the following within 3 months prior to informed consent: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy device (CRTD), active treatment for cancer or other malignant disease, uncontrolled congestive heart disease (NYHA class \>3), acute psychosis or major psychiatric disorders or continued substance abuse, other neurological (than PD) or orthopaedic impairment that significantly impacts on gait; * Participant self-reports daily falls; * Participation in another interventional study, with or without an investigational medicinal product (IMP) or device (IMD)
Frequently Asked Questions
Who can join the NCT07580612 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson Disease, Idiopathic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07580612 currently recruiting?
Yes, NCT07580612 is actively recruiting participants. Visit ClinicalTrials.gov or contact KU Leuven to inquire about joining.
Where is the NCT07580612 trial being conducted?
This trial is being conducted at Leuven, Belgium, Hamburg, Germany, Tel Aviv, Israel.
Who is sponsoring the NCT07580612 clinical trial?
NCT07580612 is sponsored by KU Leuven. The trial plans to enroll 126 participants.
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