Clinical trial NCT04931303: Digital GaitCare - Therapy Monitoring in the Home Environment of Patients With Parkinson
Official title: Digital GaitCare - Therapy Monitoring in the Home Environment of Patients With Parkinson Via Digital Gait Analysis and Patient Feedback
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Gait Disorders, Neurologic
Keywords: Parkinson
Gait Analysis
Digital Health
Home-Monitoring
Lead sponsor: Medical Valley Digital Health Application Center GmbH
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Erlangen
name: University of Regensburg
name: Philipps University Marburg
name: Hospital Rummelsberg
name: NeuroPoint GmbH
name: Portabiles HealthCare Technologies GmbH
name: Systemhaus Ulm GmbH
name: Fraunhofer Institute for Integrated Circuits IIS
name: Friedrich-Alexander-Universität Erlangen-Nürnberg
name: University of Luxembourg
name: Leibniz Centre for European Economic Research GmbH
First posted: 2021-06-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be enrolled during their routine outpatient or physician visit or inpatient stay.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in gait parameters (stride length) during 4x10 meter gait test (4x10m) performed at clinic
timeFrame: day 1 and day 60
measure: Difference in gait parameters (stride time) during 4x10 meter gait test (4x10m) performed at clinic
timeFrame: day 1 and day 60
measure: Difference in gait parameters (gait speed) during 4x10 meter gait test (4x10m) performed at clinic
timeFrame: day 1 and day 60
measure: Difference in gait parameters (heel-strike angle) during 4x10 meter gait test (4x10m) performed at clinic
timeFrame: day 1 and day 60
measure: Difference in gait parameters (toe-off angle) during 4x10 meter gait test (4x10m) performed at clinic
timeFrame: day 1 and day 60
measure: Difference in gait parameters (foot-clearance) during 4x10 meter gait test (4x10m) performed at clinic
timeFrame: day 1 and day 60
measure: Difference in gait parameters (variability) during 4x10 meter gait test (4x10m) performed at clinic
timeFrame: day 1 and day 60
measure: Difference in time of 1 x 10 meter gait test (1x10m) performed at baseline versus closeout
timeFrame: day 1 and day 60
measure: Difference in time of Timed-Up-and-Go Test (TUG) performed at baseline versus closeout
timeFrame: day 1 and day 60
measure: Difference in Unified Parkinson's Disease Rating Scale III (UPDRS III) Motor Score evaluated at baseline versus closeout
timeFrame: day 1 and day 60
measure: Difference in Shared-Decision-Making-Questionaire-9 (SDM-Q9) evaluated at baseline versus closeout
timeFrame: day 1 and day 60
measure: Difference in Parkinsons-Disease-Questionaire (PDQ-39) evaluated at baseline versus closeout
timeFrame: day 1 and day 60
measure: Difference in Parkinson-specific-health-literacy evaluated at baseline versus closeout
timeFrame: day 1 and day 60
measure: Number of useful Patient-Physician-Contacts evaluated at closeout
timeFrame: day 60
measure: System Usability Scale (SUS) and modified SUS evaluated at closeout
timeFrame: day 60
measure: Collecting gait parameters (stride length) during gait tests and monitoring at home
timeFrame: day 1 to day 60
measure: Collecting gait parameters (stride time) during gait tests and monitoring at home
timeFrame: day 1 to day 60
measure: Collecting gait parameters (gait speed) during gait tests and monitoring at home
timeFrame: day 1 to day 60
measure: Collecting gait parameters (heel-strike angle) during gait tests and monitoring at home
timeFrame: day 1 to day 60
measure: Collecting gait parameters (toe-off angle) during gait tests and monitoring at home
timeFrame: day 1 to day 60
measure: Collecting gait parameters (foot clearance) during gait tests and monitoring at home
timeFrame: day 1 to day 60
measure: Collecting gait parameters (variability) during gait tests and monitoring at home
timeFrame: day 1 to day 60
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen
city: Marburg
country: Germany
facility: Philipps University Marburg Medical Center
city: Regensburg
country: Germany
facility: University of Regensburg
city: Schwarzenbruck
country: Germany
facility: Hospital Rummelsberg
city: Ulm
country: Germany
facility: Neuropoint GmbH
Study officials:
affiliation: Molekulare Neurologie, Universitätsklinikum Erlangen
name: Jürgen Winkler, Professor
role: PRINCIPAL_INVESTIGATOR
References: