Fraunhofer Institute for Integrated Circuits IIS
Fraunhofer Institute for Integrated Circuits IIS
Clinical study "ParkinsonGo"

ParkinsonGo clinical study: gait analysis app determines health status at home

Evaluation of positive care effects and health economic significance of a patient-centered gait analysis app for use in the home with Tele-Health-Monitoring

DPM.research in use for patients with Parkinson's disease

Goal

In this EU-funded study, the CE-certified ParkinsonGo app ("Mobile GaitLab Care 2.0"; Portabiles HCT, Erlangen, Germany), will be used. The primary goal of the study is to evaluate the positive care effects that result from the home use of ParkinsonGo for the patient. Another aspect to be assessed is the health economic benefit of supplementary telehealth support (the patient app), separate from the app-mediated effects.

The project objectives will be evaluated in a 3-arm (N=30 per arm), randomized-controlled, multicenter, clinical, (non-AMG, non-MPG) study. During a maximum study duration of 180 days, the two intervention groups using the app alone (IG 1) or the app combined with tele-health support (IG 2) will be compared against a control group (KG) receiving therapy in the conservative care scenario. All study data from the clinical trials will be entered via the Fraunhofer IIS study management system "DPM Research".

Partners

  • University Hospital Erlangen | Department of Molecular Neurology (german)
  • Portabiles HealthCare Technologies GmbH
  • Friedrich-Alexander Universität Erlangen-Nuremberg | Chair of Computer Science 14 - Machine Learning and Data Analytics
  • University of Luxembourg | Luxembourg Centre for Systems Biomedicine
  • Fraunhofer IIS | Mobile Health Lab

 

Motivation

In neurodegenerative diseases, such as Parkinson's syndrome, gait disturbances and movement restrictions occur that significantly impair patients in carrying out their daily lives. Targeted feedback on the patient's state of health, supports therapy decisions made in close communication between doctor and patient (shared decision making). Sensor-based monitoring has the potential to register objective target parameters of the disease independently of an on-site presentation to the physician and to make this information available to physicians and patients via telemedical data management in order to jointly design the therapy.
 

Digital tools for conducting and evaluating clinical studies

  • Digital registration and evaluation of questionnaires based on the study management system DPM.research
  • Integration of the Mobile GaitLab Web Portal for physicians to simplify processes
  • Documentation of tele-health support

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