An observational study in Parkinson Disease and Gait Disorders, Neurologic, sponsored by Medical Valley Digital Health Application Center GmbH. Completed at 5 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-24.
Sponsored by Medical Valley Digital Health Application Center GmbH · Observational
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.
4,585 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's enrollment of 31 is below the median of 97 across 1,081 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Medical Valley Digital Health Application Center GmbH is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study participants will be enrolled during their routine outpatient or physician visit or inpatient stay.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.)
Time frame: day 60
Collecting gait parameters (stride length) during gait tests and monitoring at home
Collection of gait parameters (stride length in cm)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: day 1 to day 60
Collecting gait parameters (variability) during gait tests and monitoring at home
Collection of gait parameters (variability in percent)
Time frame: day 1 to day 60
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical Valley Digital Health Application Center GmbH