AID-FOG: Artificial Intelligence-Driven Freezing of Gait Detection in the Home

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKU Leuven

About this trial

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

Qualifiers

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;

Disqualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

126 Participants
are grouped into 3 trial groups

Sponsors and collaborators

KU Leuven

Lead sponsor

Michael J. Fox Foundation for Parkinson's Research

Collaborator

Tel Aviv Medical Center

Collaborator

Medical School Hamburg

Collaborator