Skip to main content
OpenTrials
Completed

NCT Number: NCT04931303

Digital GaitCare - Therapy Monitoring in the Home Environment of Patients With Parkinson

Gait disturbances and movement restrictions occur frequently in Parkinson's disease. Patient-centered monitoring with objective aids in the patient's daily life, supports and promotes therapy decisions made by physicians and patients. Technical, sensor-based monitoring has the potential to generate objective target parameters at any point in time during therapy (patient journey), representing the state of health and its progression, and to make this information available to physicians and patients via telemedical data management. In this study, the gait analysis system "Mobile GaitLab Home 2.0", consisting of sensors for gait data acquisition, a smartphone application for study participants (Mobile GaitLab app) and a web portal for physicians (Mobile GaitLab portal) is used for data collection.

The research question is divided into three sub-objectives: First, the study explores and tests how technically generated parameters of sensor-based gait analysis can map the symptom "bradykinesis". The second goal is the explorative investigation of how a tele-health service support with low-threshold access to medical professionals, can be integrated into the care process. The third goal is the implementation evaluation of the technological developments. Here, it is examined to determine the extent to which the implementation of gait data and patient feedback (PROMs) in the patient-centered care process within the framework of clinical decision support contributes to early gait-associated therapy optimization and thus improves the general health of patients and how initial indications of positive care effects for patients can be derived.

During a 60-day observation phase, study participants use the gait analysis system, which records their gait pattern throughout the day and collects data via the Mobile GaitLab app. Study participants are asked to perform standardized gait tests in the home environment several times a day, in addition to continuous measurements during the awake phase. Frequency of data collection is controlled by Mobile GaitLab Home 2.0 and can be flexibly adjusted to the study participant's health status and therapy. The Mobile GaitLab app uses questionnaires to record data on gait safety, activity, general well-being, and events relevant to the disease. An evaluation of these data (PROMs) and the results from the gait analyses, are visualized for the study participants via the Mobile GaitLab app.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Gait Disorders, Neurologic Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Erlangen, Erlangen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Idiopathic Parkinson's disease (H&Y I-IV)
  • Age > 18 years
  • Ability to walk > 4 x 10 m without assistance
  • Ability to speak and read
  • Ability to use an application that can be mapped on a smart device
  • Informed consent of the study participant
  • Willingness of the study participant to take therapy measures (e.g., medication therapy, exercise therapy)

Exclusion criteria

  • Tremor-dominant Parkinson's syndrome without involvement of the lower extremities
  • Aphasia and alexia
  • Visual disturbances that make reading impossible
  • Higher-grade movement disorders, with high risk of falls and non-independent ability to walk
  • Higher grade cognitive deficits
  • Inability of the study participant to understand the information and procedures of the study

Treatment and study plan

Primary outcomes

  1. Difference in gait parameters (stride length) during 4x10 meter gait test (4x10m) performed at clinic

    Time frame: day 1 and day 60

    Difference in stride length in cm during 4x10m performed at clinic

  2. Difference in gait parameters (stride time) during 4x10 meter gait test (4x10m) performed at clinic

    Time frame: day 1 and day 60

    Difference in stride time in seconds during 4x10m performed at clinic

  3. Difference in gait parameters (gait speed) during 4x10 meter gait test (4x10m) performed at clinic

    Time frame: day 1 and day 60

    Difference in gait speed in m/s during 4x10m performed at clinic

  4. Difference in gait parameters (heel-strike angle) during 4x10 meter gait test (4x10m) performed at clinic

    Time frame: day 1 and day 60

    Difference in heel-strike angle in degree during 4x10m performed at clinic

  5. Difference in gait parameters (toe-off angle) during 4x10 meter gait test (4x10m) performed at clinic

    Time frame: day 1 and day 60

    Difference in toe-off angle in degree during 4x10m performed at clinic

  6. Difference in gait parameters (foot-clearance) during 4x10 meter gait test (4x10m) performed at clinic

    Time frame: day 1 and day 60

    Difference in foot clearance in cm during 4x10m performed at clinic

  7. Difference in gait parameters (variability) during 4x10 meter gait test (4x10m) performed at clinic

    Time frame: day 1 and day 60

    Difference in variability in percent during 4x10m performed at clinic

  8. Difference in time of 1 x 10 meter gait test (1x10m) performed at baseline versus closeout

    Time frame: day 1 and day 60

    Difference in time, measured in seconds of 6 meter constant walking within the 10-meter gait test at baseline and at closeout

  9. Difference in time of Timed-Up-and-Go Test (TUG) performed at baseline versus closeout

    Time frame: day 1 and day 60

    Difference in time, measured in seconds of TUG at baseline and at closeout

  10. Difference in Unified Parkinson's Disease Rating Scale III (UPDRS III) Motor Score evaluated at baseline versus closeout

    Time frame: day 1 and day 60

    Difference in UPDRS III Motor Score (range from 0 to 56, Lower scores mean a better outcome) at baseline and at closeout

  11. Difference in Shared-Decision-Making-Questionaire-9 (SDM-Q9) evaluated at baseline versus closeout

    Time frame: day 1 and day 60

    Difference in SDM-Q9 (range from 0 to 45, Higher scores mean a better outcome) at baseline and at closeout

  12. Difference in Parkinsons-Disease-Questionaire (PDQ-39) evaluated at baseline versus closeout

    Time frame: day 1 and day 60

    Difference in PDQ-39 (range from 0 to 100, Lower scores mean a better outcome) at baseline and at closeout

  13. Difference in Parkinson-specific-health-literacy evaluated at baseline versus closeout

    Time frame: day 1 and day 60

    Difference in Parkinson-specific-health-literacy (range from 0 to 100, Higher scores mean a better outcome) at baseline and at closeout

  14. Number of useful Patient-Physician-Contacts evaluated at closeout

    Time frame: day 60

    Counted number of useful Patient-Physician-Contacts during study duration (range from 0 to individual number of Patient-Physician-Contacts) evaluated at closeout

  15. System Usability Scale (SUS) and modified SUS evaluated at closeout

    Time frame: day 60

    SUS score per patient - range from 0 to 100 score points (Higher scores mean a better outcome.)

  16. Collecting gait parameters (stride length) during gait tests and monitoring at home

    Time frame: day 1 to day 60

    Collection of gait parameters (stride length in cm)

  17. Collecting gait parameters (stride time) during gait tests and monitoring at home

    Time frame: day 1 to day 60

    Collection of gait parameters (stride time in seconds)

  18. Collecting gait parameters (gait speed) during gait tests and monitoring at home

    Time frame: day 1 to day 60

    Collection of gait parameters (gait speed in m/s)

  19. Collecting gait parameters (heel-strike angle) during gait tests and monitoring at home

    Time frame: day 1 to day 60

    Collection of gait parameters (heel-strike angle in degree)

  20. Collecting gait parameters (toe-off angle) during gait tests and monitoring at home

    Time frame: day 1 to day 60

    Collection of gait parameters (toe-off angle in degree)

  21. Collecting gait parameters (foot clearance) during gait tests and monitoring at home

    Time frame: day 1 to day 60

    Collection of gait parameters (foot clearance in cm)

  22. Collecting gait parameters (variability) during gait tests and monitoring at home

    Time frame: day 1 to day 60

    Collection of gait parameters (variability in percent)

Sponsors and collaborators

Lead sponsor

Medical Valley Digital Health Application Center GmbH

Industry

Collaborators

  • Fraunhofer Institute for Integrated Circuits IIS
  • Friedrich-Alexander-Universität Erlangen-Nürnberg
  • Hospital Rummelsberg
  • Leibniz Centre for European Economic Research GmbH
  • NeuroPoint GmbH
  • Philipps University Marburg
  • Portabiles HealthCare Technologies GmbH
  • Systemhaus Ulm GmbH
  • University Hospital Erlangen
  • University of Luxembourg
  • University of Regensburg

Registry information

Official study title

Digital GaitCare - Therapy Monitoring in the Home Environment of Patients With Parkinson Via Digital Gait Analysis and Patient Feedback

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2021
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.