Detecting freezing of gait at home using AI and wearable sensors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.