RecruitingNCT07580612

Artificial Intelligence-Driven Freezing Of Gait Detection in the Home: Investigating How Free-living Activities Affect the Algorithm

Sponsor: KU Leuven

Trial Details

ConditionParkinson Disease, Idiopathic, Freezing of Gait, Validation, Wearable Sensors, Artifical Intelligence
StatusRecruiting
Participants126
Est. Completion1 June 2027
Last Updated12 May 2026

Primary Outcome

Comparing the agreement between AID-FOG and gold-standard expert annotation to detect the percentage of time spent with freezing of gait (FOG) in relation to total time duration (%TF).

Eligibility Criteria

Inclusion 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)

Trial Sites

Countries

BelgiumGermanyIsrael
View Registry Entry

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