Trial document




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  DRKS00015085

Trial Description

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Title

FallriskPD: fall risk evaluation in Parkinson’s disease using intelligent gait analysis

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Trial Acronym

FallRiskPD

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Special shoes with integrated sensors analyzing gait and falls characteristics in patients with Parkinson's disease under real-life conditions. Patients can be timely warned about an impending fall if relevant changes in relation to fall risk occurs in their gait pattern.

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Brief Summary in Scientific Language

The overall goal of the project is the investigation of novel machine learning based algorithms that are able to predict the fall risk based on specific gait patterns, captured by shoe integrated inertial sensors in patients with Parkinson's disease.
The data for the evaluation of fall risk associated gait patterns will be acquired by means of a continuous long-term monitoring system.

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Organizational Data

  •   DRKS00015085
  •   2018/09/03
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  •   yes
  •   Approved
  •   165_18B , Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

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Health Condition or Problem studied

  •   G20.1 -  [generalization G20: Parkinson disease]
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Interventions/Observational Groups

  •   Two independent longitudinal trail phases will be conducted on different study populations. In trail phase 1, continuously home-monitoring with a mobile gait analysis system over a 2 week period is carried out to assign patients into fall risk categories regarding their gait pattern and clinical assessments. The developed methods for prospective recognition of the fall risk will be proven on a comparable patient cohort within the second trail phase. With the use of a mobile gait analysis system over four weeks in patients home environments, changes in fall risk should be recognized and rated.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

1. Retrospective classification of patients into fall risk categories regarding sensor-based gait parameters continuously recorded over a 2 weeks period in home environments.
2. Prospective identification of the fall risk sensor-based gait parameters continuously recorded over a 4 weeks period in home environments.

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Secondary Outcome

1. Frequency of falls in pre-, post- and follow up-assessments.
2. Fear of falling in pre-, post- and follow up-assessments.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/09/05
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Diagnosis of a Parkinson syndrome in accordance with the guideline of the German Society of Neurology (Hoehn & Yahr stadium I-III)
- Ability to walk for 2 Minutes without assistance
- Ability to speak and read
- Ability to use an application running on a smart device
- informed consent with understanding of the study procedures

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Exclusion Criteria

- Aphasia and Alexia
- Impaired vision which makes reading unfeasible
- Regular use of gait aids
- Decompensated cardiopulmonary restrictions
- Maximal walking distance < 100 meter
- Inability to understand the informed consent and the study procedures
- Distinct musculoskeletal disorder, which highly restricts movement and gait abilities

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Addresses

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    • Universitätsklinikum Erlangen, Molekular-Neurologische Abteilung
    • Mr.  Prof. Dr. med.  Jürgen  Winkler 
    • Schwabachanlage 6
    • 91054  Erlangen
    • Germany
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    • Machine Learning and Data Analytics Lab, Department of Computer Science, Friedrich-Alexander Universität Erlangen-Nürnberg (FAU)Erlangen-Nürnberg
    • Mr.  Prof. Dr.  Björn  Eskofier 
    • Carl-Thiersch-Str. 2b
    • 91052  Erlangen
    • Germany
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    • Portabiles HealthCare Technologies GmbH
    • Mr.  Ralph  Steidl 
    • Nordostpark 89
    • 90411  Nürnberg
    • Germany
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    • Molekulare Neurologie, Universitätsklinikum Erlangen, Friedrich-Alexander Universität Erlangen-Nürnberg
    • Mr.  Prof. Dr.  Jochen  Klucken 
    • Schwabachanlage 6
    • 91054  Erlangen
    • Germany
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    • Molekulare Neurologie, Universitätsklinikum Erlangen, Friedrich-Alexander Universität Erlangen-Nürnberg
    • Mr.  Till  Gladow 
    • Schwabachanlage 6
    • 91054  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Bayerisches Staatsminesterium für Wirtschaft und Medien, Energie und Technologie
    • 80525  München
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.