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

5 de maio de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Tipo de estudo

Observacional

Inscrição (Estimado)

126

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
  • Bélgica
      • Leuven, Bélgica, 3001
        • Recrutamento
        • Department of Rehabilitation Sciences
        • Contato:
        • Contato:
        • Investigador principal:
          • Moran Gilat
  • Israel
      • Tel Aviv, Israel, 64
        • Ainda não está recrutando
        • Center for the study of movement, cognition and mobility
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Controles saudáveis
Idosos saudáveis
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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).
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
F1-score
Prazo: 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
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
AID-FOG version 2.0 (percentage TF)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

KU Leuven

Colaboradores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

22 de setembro de 2025

Conclusão Primária (Estimado)

1 de junho de 2027

Conclusão do estudo (Estimado)

1 de junho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

2 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de maio de 2026

Primeira postagem (Real)

12 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • S70220
  • MJFF-024628 (Número de outro subsídio/financiamento: Micheal J. Fox)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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