Parkinson DiseaseNCT04931303
Digital GaitCare - Therapy Monitoring in the Home Environment of Patients With Parkinson
An observational study of Parkinson Disease and Gait Disorders, Neurologic, run by Medical Valley Digital Health Application Center GmbH at 5 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Gait Disorders, Neurologic
- How many people
- 31 participants
- Where
- 5 sitesGermany
- Study dates
- 24 Jun 2021to 15 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be enrolled during their routine outpatient or physician visit or inpatient stay.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
University Hospital Erlangen
Erlangen, 91054
Philipps University Marburg Medical Center
Marburg, 35043
University of Regensburg
Regensburg, 93053
Hospital Rummelsberg
Schwarzenbruck, 90592
Neuropoint GmbH
Ulm, 89073
About this study
Official title: Digital GaitCare - Therapy Monitoring in the Home Environment of Patients With Parkinson Via Digital Gait Analysis and Patient Feedback
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
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.)
Measured: day 60
Collecting gait parameters (stride length) during gait tests and monitoring at home
Collection of gait parameters (stride length in cm)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: day 1 to day 60
Collecting gait parameters (variability) during gait tests and monitoring at home
Collection of gait parameters (variability in percent)
Measured: day 1 to day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start24 Jun 2021
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Valley Digital Health Application Center GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Erlangen, University of Regensburg, Philipps University Marburg, Hospital Rummelsberg, NeuroPoint GmbH, Portabiles HealthCare Technologies GmbH, Systemhaus Ulm GmbH, Fraunhofer Institute for Integrated Circuits IIS, Friedrich-Alexander-Universität Erlangen-Nürnberg, University of Luxembourg, Leibniz Centre for European Economic Research GmbH
- Responsible party
- Sponsor
- Investigators
- Jürgen Winkler, Professor, Principal investigator, Molekulare Neurologie, Universitätsklinikum Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931303
- Sponsor's protocol ID
- 1
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital GaitCare - Therapy Monitoring in the Home Environment of Patients With Parkinson Via Digital Gait Analysis and Patient Feedback
- ClinicalTrials.gov ID
- NCT04931303
- Acronym / sponsor ID
- 1
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Keywords
- Parkinson, Gait Analysis, Digital Health, Home-Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Medical Valley Digital Health Application Center GmbHIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Erlangen, University of Regensburg, Philipps University Marburg, Hospital Rummelsberg, NeuroPoint GmbH, Portabiles HealthCare Technologies GmbH, Systemhaus Ulm GmbH, Fraunhofer Institute for Integrated Circuits IIS, Friedrich-Alexander-Universität Erlangen-Nürnberg, University of Luxembourg, Leibniz Centre for European Economic Research GmbH
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be enrolled during their routine outpatient or physician visit or inpatient stay.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Winkler, Professor principal investigator
Molekulare Neurologie, Universitätsklinikum Erlangen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Gait Disorders, Neurologic, run by Medical Valley Digital Health Application Center GmbH at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in gait parameters (stride length) during 4x10 meter gait test (4x10m) performed at clinic (time frame: day 1 and day 60). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.