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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04931303
• Other study ID #: 1
• Status: Completed
• Start date: June 24, 2021
• Est. completion date: February 15, 2022

Study information

• Verified date: June 2021
• Source: Medical Valley Digital Health Application Center GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases
• Parkinson Disease

Locations

Country	Name	City	State
Germany	University Hospital Erlangen	Erlangen
Germany	Philipps University Marburg Medical Center	Marburg
Germany	University of Regensburg	Regensburg
Germany	Hospital Rummelsberg	Schwarzenbruck
Germany	Neuropoint GmbH	Ulm

Sponsors (12)

Lead Sponsor	Collaborator
Medical Valley Digital Health Application Center GmbH	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 Medical Center, Portabiles HealthCare Technologies GmbH, Systemhaus Ulm GmbH, University Hospital Erlangen, University of Luxembourg, University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in gait parameters (stride length) during 4x10 meter gait test (4x10m) performed at clinic	Difference in stride length in cm during 4x10m performed at clinic	day 1 and day 60
Primary	Difference in gait parameters (stride time) during 4x10 meter gait test (4x10m) performed at clinic	Difference in stride time in seconds during 4x10m performed at clinic	day 1 and day 60
Primary	Difference in gait parameters (gait speed) during 4x10 meter gait test (4x10m) performed at clinic	Difference in gait speed in m/s during 4x10m performed at clinic	day 1 and day 60
Primary	Difference in gait parameters (heel-strike angle) during 4x10 meter gait test (4x10m) performed at clinic	Difference in heel-strike angle in degree during 4x10m performed at clinic	day 1 and day 60
Primary	Difference in gait parameters (toe-off angle) during 4x10 meter gait test (4x10m) performed at clinic	Difference in toe-off angle in degree during 4x10m performed at clinic	day 1 and day 60
Primary	Difference in gait parameters (foot-clearance) during 4x10 meter gait test (4x10m) performed at clinic	Difference in foot clearance in cm during 4x10m performed at clinic	day 1 and day 60
Primary	Difference in gait parameters (variability) during 4x10 meter gait test (4x10m) performed at clinic	Difference in variability in percent during 4x10m performed at clinic	day 1 and day 60
Primary	Difference in time of 1 x 10 meter gait test (1x10m) performed at baseline versus closeout	Difference in time, measured in seconds of 6 meter constant walking within the 10-meter gait test at baseline and at closeout	day 1 and day 60
Primary	Difference in time of Timed-Up-and-Go Test (TUG) performed at baseline versus closeout	Difference in time, measured in seconds of TUG at baseline and at closeout	day 1 and day 60
Primary	Difference in Unified Parkinson's Disease Rating Scale III (UPDRS III) Motor Score evaluated at baseline versus closeout	Difference in UPDRS III Motor Score (range from 0 to 56, Lower scores mean a better outcome) at baseline and at closeout	day 1 and day 60
Primary	Difference in Shared-Decision-Making-Questionaire-9 (SDM-Q9) evaluated at baseline versus closeout	Difference in SDM-Q9 (range from 0 to 45, Higher scores mean a better outcome) at baseline and at closeout	day 1 and day 60
Primary	Difference in Parkinsons-Disease-Questionaire (PDQ-39) evaluated at baseline versus closeout	Difference in PDQ-39 (range from 0 to 100, Lower scores mean a better outcome) at baseline and at closeout	day 1 and day 60
Primary	Difference in Parkinson-specific-health-literacy evaluated at baseline versus closeout	Difference in Parkinson-specific-health-literacy (range from 0 to 100, Higher scores mean a better outcome) at baseline and at closeout	day 1 and day 60
Primary	Number of useful Patient-Physician-Contacts evaluated at closeout	Counted number of useful Patient-Physician-Contacts during study duration (range from 0 to individual number of Patient-Physician-Contacts) evaluated at closeout	day 60
Primary	System Usability Scale (SUS) and modified SUS evaluated at closeout	SUS score per patient - range from 0 to 100 score points (Higher scores mean a better outcome.)	day 60
Primary	Collecting gait parameters (stride length) during gait tests and monitoring at home	Collection of gait parameters (stride length in cm)	day 1 to day 60
Primary	Collecting gait parameters (stride time) during gait tests and monitoring at home	Collection of gait parameters (stride time in seconds)	day 1 to day 60
Primary	Collecting gait parameters (gait speed) during gait tests and monitoring at home	Collection of gait parameters (gait speed in m/s)	day 1 to day 60
Primary	Collecting gait parameters (heel-strike angle) during gait tests and monitoring at home	Collection of gait parameters (heel-strike angle in degree)	day 1 to day 60
Primary	Collecting gait parameters (toe-off angle) during gait tests and monitoring at home	Collection of gait parameters (toe-off angle in degree)	day 1 to day 60
Primary	Collecting gait parameters (foot clearance) during gait tests and monitoring at home	Collection of gait parameters (foot clearance in cm)	day 1 to day 60
Primary	Collecting gait parameters (variability) during gait tests and monitoring at home	Collection of gait parameters (variability in percent)	day 1 to day 60