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

NCT04931303 | Completed

• 1 other identifier: 1
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 5

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.

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Keywords

Parkinson; Gait Analysis; Digital Health; Home-Monitoring

Outcome Measures

Primary Outcomes (22)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

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

  Collection of gait parameters (variability in percent)

  day 1 to day 60

Study Arms (1)

Study Group

Enrolled patients receive a medical device which monitors gait quality and collects information about the patients health status. Possible changes of intervention (drug or physical therapy) within the observational phase (8 weeks) are initiated and prescribed by physicians as a result of routine care process or patient contact based on their (deteriorated) health status. With the chosen endpoints, changes of patients empowerment, gait quality and system usability by using a monitoring device are monitored.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be enrolled during their routine outpatient or physician visit or inpatient stay.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Valley Digital Health Application Center GmbH: lead
• University Hospital Erlangen: collaborator
• University of Regensburg: collaborator
• Philipps University Marburg: collaborator
• Hospital Rummelsberg: collaborator
• NeuroPoint GmbH: collaborator
• Portabiles HealthCare Technologies GmbH: collaborator
• Systemhaus Ulm GmbH: collaborator
• Fraunhofer Institute for Integrated Circuits IIS: collaborator
• Friedrich-Alexander-Universität Erlangen-Nürnberg: collaborator
• University of Luxembourg: collaborator
• Leibniz Centre for European Economic Research GmbH: collaborator

Study Sites (5)

University Hospital Erlangen

Erlangen, 91054, Germany

Location

Philipps University Marburg Medical Center

Marburg, 35043, Germany

Location

University of Regensburg

Regensburg, 93053, Germany

Location

Hospital Rummelsberg

Schwarzenbruck, 90592, Germany

Location

Neuropoint GmbH

Ulm, 89073, Germany

Location

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

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

Study Officials

• Jürgen Winkler, Professor

  Molekulare Neurologie, Universitätsklinikum Erlangen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 18, 2021
• Study Start: June 24, 2021
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: August 24, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)