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

5 de mayo de 2026 actualizado por: Moran Gilat, KU Leuven

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

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Tipo de estudio

De observación

Inscripción (Estimado)

126

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
  • Bélgica
      • Leuven, Bélgica, 3001
        • Reclutamiento
        • Department of Rehabilitation Sciences
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Moran Gilat
  • Israel
      • Tel Aviv, Israel, 64
        • Aún no reclutando
        • Center for the study of movement, cognition and mobility
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

People with PD and healthy age-matched controls will be recruited from three primary sites, namely KU Leuven, Hamburg Medical Center, and Tel-Aviv Sourasky Medical Center.

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Controles saludables
Adultos mayores sanos
Freezers
Patients with Parkinson's disease who self-report to experience Freezing of Gait daily.
Non-freezers
Patients with Parkinson's disease who do not experience Freezing of Gait.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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).
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The primary outcome (percentage of time spent with FOG in relation to total task duration = %TF) will be established by manual annotations of video footage by an experienced assessor (=gold-standard reference) and by the automated AID-FOG algorithm v1.0 applied post-hoc (i.e. offline) to IMU data collected during the same walking tasks. This will be calculated for standardized walking tasks on which the AID-FOG algorithm has been trained, standardized walking tasks on which the AID-FOG algorithm was not trained, and a free-living walking condition on which the AID-FOG algorithm was not trained.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
F1-score
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
Same as primary outcome, but now for the F1-score (rather than percent TF). F1 scores range between 0 and 1, the higher the score the better.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
Number of FOG episodes
Periodo de tiempo: T0: free-living gait (5 hours), T1: free-living gait (5 hours) and T2: standardized gait (4 hours)
Same as primary outcome, but now for the absolute number of FOG episodes.
T0: free-living gait (5 hours), T1: free-living gait (5 hours) and T2: standardized gait (4 hours)
The performance of the AID-FOG algorithm to differentiate between the FOG manifestations.
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
Freezing of gait (FOG) manifests in multiple forms, including akinetic and kinetic subtypes, which may be associated with trembling or occur without it. This study investigates the performance of AID-FOG in discriminating between these manifestations, using expert annotations as the reference standard.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
Comparing performance of AID-FOG to detect freezing in OFF and ON medication states.
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The FOG outcomes as obtained by the human expert and the offline AID-FOG algorithm v1.0 will be calculated for both the OFF and ON medication states. These scores will be compared to evaluate the change in algorithm performance depending on medication status. The FOG outcomes will be the percentage TF which ranges between 0-100 percent. The higher the percentage the more freezing the patient has. But also the F1-score which ranges between 0-1. The higher the score the more overlap there is between the expert and the algorithm.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
Consistency of FOG detection with AID-FOG compared between two free-living assessments
Periodo de tiempo: T0= test day 1: free-living gait (5 hours) and T1= test day 2: free-living gait (5 hours)
The agreement in FOG detection (%TF, F1-score) between the AID-FOG algorithm and the gold-standard human annotations will be compared between the two free-living test days.
T0= test day 1: free-living gait (5 hours) and T1= test day 2: free-living gait (5 hours)
The number of false detections of FOG episodes during free-living
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The absolute sum of false detections made by the algorithm.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
Comparing AID-FOG with subjective FOG
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The FOG outcomes obtained with AID-FOG will be correlated to the total score of the New Freezing of Gait Questionnaire (NFOGQ) and Patient Reported Outcomes of FOG (PRO).
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
Performance of automated FOG detection during free-living mobility
Periodo de tiempo: 1 week of free-living mobility with IMU
The FOG outcomes obtained with AID-FOG offline will be calculated from multiple days of free-living mobility IMU data. These outcomes will be correlated to FOG severity as determined during the observed walking tasks of the project and self-reported FOG severity.
1 week of free-living mobility with IMU

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
AID-FOG version 2.0 (percentage TF)
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)

The data obtained in the study will be used to train the AID-FOG algorithm v1.0. This trained AID-FOG algorithm v2.0 will be evaluated using the same listed outcome measures, using a leave-one-subject-out approach.

Percentage of time spent with FOG in relation to total task duration (= %TF) will be established by manual annotations of video footage by an experienced assessor (=gold-standard reference) and by the automated AID-FOG algorithm v2.0 applied post-hoc (i.e. offline) to IMU data collected during the same walking tasks. This will be calculated for standardized walking tasks on which the AID-FOG algorithm has been trained, standardized walking tasks on which the AID-FOG algorithm was not trained, and a free-living walking condition on which the AID-FOG algorithm was not trained.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
AID-FOG version 2.0 (F1-score)
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The data obtained in the study will be used to train the AID-FOG algorithm v1.0. This trained AID-FOG algorithm v2.0 will be evaluated using the same listed outcome measures, using a leave-one-subject-out approach. Same as percentage TF, but now for the F1-score (rather than percent TF). F1 scores range between 0 and 1, the higher the score the better.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
AID-FOG version 2.0 (Number of FOG episodes)
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The data obtained in the study will be used to train the AID-FOG algorithm v1.0. This trained AID-FOG algorithm v2.0 will be evaluated using the same listed outcome measures, using a leave-one-subject-out approach. Same as percentage TF, but now for the absolute number of FOG episodes.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
AID-FOG version 2.0 (FOG manifestations)
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The data obtained in the study will be used to train the AID-FOG algorithm v1.0. This trained AID-FOG algorithm v2.0 will be evaluated using the same listed outcome measures, using a leave-one-subject-out approach. The performance of the AID-FOG algorithm v2.0 to discriminate between the FOG manifestations. Freezing of gait (FOG) manifests in multiple forms, including akinetic and kinetic subtypes, which may be associated with trembling or occur without it. This study investigates the performance of AID-FOG in discriminating between these manifestations, using expert annotations as the reference standard.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
AID-FOG version 2.0 (OFF/ON medication)
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The data obtained in the study will be used to train the AID-FOG algorithm v1.0. This trained AID-FOG algorithm v2.0 will be evaluated using the same listed outcome measures, using a leave-one-subject-out approach. Comparing performance of AID-FOG v2.0 to detect freezing in OFF and ON medication states. The FOG outcomes as obtained by the human expert and the offline AID-FOG algorithm v2.0 will be calculated for both the OFF and ON medication states. These scores will be compared to evaluate the change in algorithm performance depending on medication status. The FOG outcomes will be the percentage TF which ranges between 0-100 percent. The higher the percentage the more freezing the patient has. But also the F1-score which ranges between 0-1. The higher the score the more overlap there is between the expert and the algorithm.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
AID-FOG version 2.0 (consistency of detection during two free-living assessments)
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The data obtained in the study will be used to train the AID-FOG algorithm v1.0. This trained AID-FOG algorithm v2.0 will be evaluated using the same listed outcome measures, using a leave-one-subject-out approach. Consistency of FOG detection with AID-FOG v2.0 compared between two free-living assessments. The agreement in FOG detection (%TF, F1-score) between the AID-FOG algorithm v2.0 and the gold-standard human annotations will be compared between the two free-living test days.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
AID-FOG version 2.0 (number of false positives)
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The data obtained in the study will be used to train the AID-FOG algorithm v1.0. This trained AID-FOG algorithm v2.0 will be evaluated using the same listed outcome measures, using a leave-one-subject-out approach. The number of false detections (AID-FOG v2.0) of FOG episodes during free-living
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
AID-FOG version 2.0 (subjective FOG)
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The data obtained in the study will be used to train the AID-FOG algorithm v1.0. This trained AID-FOG algorithm v2.0 will be evaluated using the same listed outcome measures, using a leave-one-subject-out approach. Comparing AID-FOG v2.0 with subjective FOG. The FOG outcomes obtained with AID-FOG v2.0 will be correlated to the total score of the New Freezing of Gait Questionnaire (NFOGQ) and Patient Reported Outcomes of FOG (PRO).
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
AID-FOG online (percentage TF)
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The AID-FOG algorithm will be modified for real-time FOG detection. Performance of this AID-FOG online algorithm will be compared with AID-FOG offline versions, using the same listed outcomes. Percentage of time spent with FOG in relation to total task duration (= %TF) will be established by manual annotations of video footage by an experienced assessor (=gold-standard reference) and by the automated AID-FOG online to IMU data collected during the same walking tasks. This will be calculated for standardized walking tasks on which the AID-FOG algorithm has been trained, standardized walking tasks on which the AID-FOG algorithm was not trained, and a free-living walking condition on which the AID-FOG algorithm was not trained.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
AID-FOG online (F1-score)
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The AID-FOG algorithm will be modified for real-time FOG detection. Performance of this AID-FOG online algorithm will be compared with AID-FOG offline versions, using the same listed outcomes. Same as percentage TF, but now for the F1-score (rather than percent TF). F1 scores range between 0 and 1, the higher the score the better.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
AID-FOG online (number of FOG episodes)
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The AID-FOG algorithm will be modified for real-time FOG detection. Performance of this AID-FOG online algorithm will be compared with AID-FOG offline versions, using the same listed outcomes. Same as percentage TF, but now for the absolute number of FOG episodes.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
AID-FOG online (FOG manifestations)
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The AID-FOG algorithm will be modified for real-time FOG detection. Performance of this AID-FOG online algorithm will be compared with AID-FOG offline versions, using the same listed outcomes. The performance of the AID-FOG online algorithm to discriminate between the FOG manifestations.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
AID-FOG online (OFF/ON medication)
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The AID-FOG algorithm will be modified for real-time FOG detection. Performance of this AID-FOG online algorithm will be compared with AID-FOG offline versions, using the same listed outcomes. The FOG outcomes as obtained by the human expert and the offline AID-FOG online algorithm will be calculated for both the OFF and ON medication states. These scores will be compared to evaluate the change in algorithm performance depending on medication status. The FOG outcomes will be the percentage TF which ranges between 0-100 percent. The higher the percentage the more freezing the patient has. But also the F1-score which ranges between 0-1. The higher the score the more overlap there is between the expert and the algorithm.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
AID-FOG online (agreement of the detection between two free-living test days)
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The AID-FOG algorithm will be modified for real-time FOG detection. Performance of this AID-FOG online algorithm will be compared with AID-FOG offline versions, using the same listed outcomes. The agreement in FOG detection (%TF, F1-score) between the AID-FOG online algorithm and the gold-standard human annotations will be compared between the two free-living test days.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
AID-FOG online (number false positives)
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The AID-FOG algorithm will be modified for real-time FOG detection. Performance of this AID-FOG online algorithm will be compared with AID-FOG offline versions, using the same listed outcomes. The absolute sum of false detections made by the online algorithm.
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
AID-FOG online (subjective FOG)
Periodo de tiempo: T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
The AID-FOG algorithm will be modified for real-time FOG detection. Performance of this AID-FOG online algorithm will be compared with AID-FOG offline versions, using the same listed outcomes. Comparing AID-FOG online with subjective FOG. The FOG outcomes obtained with AID-FOG online will be correlated to the total score of the New Freezing of Gait Questionnaire (NFOGQ) and Patient Reported Outcomes of FOG (PRO).
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

KU Leuven

Colaboradores

Michael J. Fox Foundation for Parkinson's Research
Tel Aviv Medical Center
Medical School Hamburg

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de septiembre de 2025

Finalización primaria (Estimado)

1 de junio de 2027

Finalización del estudio (Estimado)

1 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

2 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de mayo de 2026

Publicado por primera vez (Actual)

12 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • S70220
  • MJFF-024628 (Otro número de subvención/financiamiento: Micheal J. Fox)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

The datasets could be made available under restricted access after publication of the results, following ethical approval and a data-transfer agreement. GDPR and privacy regulations will be adhered to.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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