Clinical trial NCT04771858: Digital Gait Analysis in the Home Environment of Patients With Multiple Sclerosis
Official title: MSgoesHome - Digital Gait Analysis in the Home Environment of Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Gait Analysis
Home-Monitoring
Lead sponsor: Medical Valley Digital Health Application Center GmbH
Sponsor class: INDUSTRY
Collaborators: name: Celgene Corporation
name: NeuroSys GmbH
name: Fraunhofer Institute for Integrated Circuits IIS
name: Portabiles HealthCare Technologies GmbH
name: University of Regensburg
First posted: 2021-02-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited at the University Hospital Regensburg via the routine university outpatient clinic of the Department and Polyclinic of Neurology.

Brief summary: The aim of this study is the development of novel telemedical examination methods based on sensor-based gait analysis in patients with multiple sclerosis (MS). In a first step, the basic technical feasibility of measuring gait parameters in MS patients under standardized conditions in the clinic and in the home environment of the study participants will be investigated.

In a subsequent two-week study phase, gait parameters (real-life monitoring) and standardized gait tests will be continuously recorded in the home environment of the study participants. The comparability of the collected gait parameters from standardized gait tests and real-life monitoring to clinical scales (e.g. EDSS) will investigate the medical applicability of gait analysis as a target parameter in MS patients.

New algorithms for detecting indication-specific gait patterns from gait analysis in patients' daily lives and their possible changes over time (progression) will be explored and implemented into the study system. In addition, a patient app annotates the standardized gait tests and collects questionnaire-based data from the study participants during real-life monitoring. Via a study tablet, the data of the gait analysis and the patient app are transmitted to a study platform (Digital Patient Manager). The clinical assessment data (neurological examination, questionnaires) can be entered via a web front-end of the study platform and assigned to the patient via a pseudonym.

A further aim of this study is to validate the technology used for its applicability in the home environment. By means of structured interviews after the study phase, the study participants will be asked about compliance and adherence.

The following scientific questions will be investigated in this project:

(a) Is gait analysis a feasible and meaningful target parameter for MS centers? b) Are gait parameters from real-life monitoring suitable biomarkers for the detection of MS symptoms? c) Can gait parameters from standardized gait tests be compared with different testing environments (clinic / home environment)? d) How do gait parameters from standardized gait tests differ from gait data from real-life monitoring? e) How is the telemedical application for the collection of gait parameters evaluated by the patients? f) Can disease progression be detected using sensor-based gait parameters from the home environment?


Eligibility criteria: Inclusion Criteria:

* Diagnosis of multiple sclerosis according to McDonald criteria
* Expanded Disability Status Scale (EDSS) 1-6
* Age \> 18 years
* Ability to speak and read
* Ability to use an application running on a smart device
* Patient informed consent

Exclusion Criteria:

* Severe difficulty walking with frequent falls
* Inability to walk at least 10 meters
* Permanent use of a wheelchair
* Severe spasticity
* Cognitive impairment with inability to give consent to protocol

Primary outcomes:
measure: Number of detected gait cycles per patient per day
timeFrame: day 1 to day 14
measure: Daily sensor wear time per patient
timeFrame: day 1 to day 14
measure: Completeness of days during 14-day field period per patient with sensor records
timeFrame: day 1 to day 14
measure: System Usability Scale (SUS)
timeFrame: day 14 (closeout visit)
Secondary outcomes:
measure: Difference in time of 25-Foot-Walk-Test (25FWT) performed at home versus 25-Foot-Walk-Test (25FWT) performed at clinic
timeFrame: day 1
measure: Difference in time of 25-Foot-Walk-Test (25FWT) performed at home versus 25-Foot-Walk-Test (25FWT) performed at clinic
timeFrame: day 14
measure: Difference in gait parameters during 25-Foot-Walk-Test (25FWT) performed at home versus 25-Foot-Walk-Test (25FWT) performed at clinic
timeFrame: day 1
measure: Difference in gait parameters during 25-Foot-Walk-Test (25FWT) performed at home versus 25-Foot-Walk-Test (25FWT) performed at clinic
timeFrame: day 14
measure: Correlation of change of Expanded Disability Status Scale (EDSS) and change of 25-Foot-Walk-Test (25FWT) performed at home
timeFrame: day 1 and day 14
measure: Correlation of change of Expanded Disability Status Scale (EDSS) and change of 25-Foot-Walk-Test (25FWT) performed at clinic
timeFrame: day 1 and day 14
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Department of Neurology, University of Regensburg
state: Bavaria
Study officials:
affiliation: Department of Neurology, University of Regensburg, Regensburg 93053, Germany
name: Ralf Linker, Professor
role: PRINCIPAL_INVESTIGATOR
References: