Detecting freezing of gait at home using AI and wearable sensors
Artificial Intelligence-Driven Freezing Of Gait Detection in the Home: Investigating How Free-living Activities Affect the Algorithm
This project tests whether an AI algorithm using wearable sensors can accurately detect freezing of gait in people with Parkinson's disease while they go about daily life at home.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Locations | 3 sites (Leuven and 2 other locations) |
| Trial ID | NCT07580612 on ClinicalTrials.gov |
What this trial studies
Researchers will equip people with Parkinson's who experience daily freezing with wearable inertial measurement unit (IMU) sensors and collect movement data in the home environment. The AI algorithm, previously trained and initially validated in laboratory walking tests, will be run on the home sensor data to flag freezing of gait episodes. Algorithm detections will be compared to reference observations from standardized assessment visits and expert-labelled events where available. The study is observational and conducted at participating centers in Leuven, Hamburg, and Tel Aviv with home monitoring between visits.
Who should consider this trial
Good fit: Adults with a neurologist-confirmed Parkinson's disease who report daily freezing of gait, can walk short distances independently, can provide informed consent, and do not live in a care facility are ideal candidates.
Not a fit: People who do not experience freezing of gait, who live in temporary or permanent care facilities, who cannot walk independently, or who cannot follow study instructions are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could allow continuous, objective detection of freezing of gait at home, helping tailor treatment and reduce fall risk.
How similar studies have performed: Laboratory-based studies and initial validations using wearable IMUs and AI have shown promising detection of freezing of gait, but reliable performance in real-world home settings is less established.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Leuven and 2 other locations
- Department of Rehabilitation Sciences — Leuven, Belgium (Recruiting)
- Sports Science and Neurorehabilitation — Hamburg, Germany (Not_yet_recruiting)
- Center for the study of movement, cognition and mobility — Tel Aviv, Israel (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.