Digital Gait Analysis in the Home Environment of Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— MSgoesHome  

Official title:

MSgoesHome - Digital Gait Analysis in the Home Environment of Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771858
• Other study ID #: MV-dmac 3445707
• Status: Completed
• Start date: March 9, 2021
• Est. completion date: June 28, 2023

Study information

• Verified date: June 2023
• Source: Medical Valley Digital Health Application Center GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 28, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Germany	Department of Neurology, University of Regensburg	Regensburg	Bavaria

Sponsors (6)

Lead Sponsor	Collaborator
Medical Valley Digital Health Application Center GmbH	Celgene Corporation, Fraunhofer Institute for Integrated Circuits IIS, NeuroSys GmbH, Portabiles HealthCare Technologies GmbH, University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of detected gait cycles per patient per day	Number of sensor-detected gait cycles (one gait cycle are two steps) per patient per day	day 1 to day 14
Primary	Daily sensor wear time per patient	Percentage of sensor wear time per patient per day - range from 0 hours (0%) to 6 hours (100%)	day 1 to day 14
Primary	Completeness of days during 14-day field period per patient with sensor records	Percentage of days with sensor data recorded per patient - range from 0 days (0%) to 14 days (100%)	day 1 to day 14
Primary	System Usability Scale (SUS)	SUS score per patient - range from 0 to 100 score points (Higher scores mean a better outcome.)	day 14 (closeout visit)
Secondary	Difference in time of 25-Foot-Walk-Test (25FWT) performed at home versus 25-Foot-Walk-Test (25FWT) performed at clinic	Difference in time, measured in seconds, of 25FWT performed at home and performed at clinic	day 1
Secondary	Difference in time of 25-Foot-Walk-Test (25FWT) performed at home versus 25-Foot-Walk-Test (25FWT) performed at clinic	Difference in time, measured in seconds, of 25FWT performed at home and performed in clinic	day 14
Secondary	Difference in gait parameters during 25-Foot-Walk-Test (25FWT) performed at home versus 25-Foot-Walk-Test (25FWT) performed at clinic	Difference in gait parameters (gait length in cm, speed in m/s, contact angle in degree, swing-through phase in percent, standing phase in percent, lateral swing in cm, toe clearance in cm, lifting angle of toes in cm, impact intensity in g, variability of these parameters and symmetry between left and right foot) during 25FWT performed at home versus 25FWT performed at clinic	day 1
Secondary	Difference in gait parameters during 25-Foot-Walk-Test (25FWT) performed at home versus 25-Foot-Walk-Test (25FWT) performed at clinic	Difference in gait parameters (gait length in cm, speed in m/s, contact angle in degree, swing-through phase in percent, standing phase in percent, lateral swing in cm, toe clearance in cm, lifting angle of toes in cm, impact intensity in g, variability of these parameters and symmetry between left and right foot) during 25FWT performed at home versus 25FWT performed at clinic	day 14
Secondary	Correlation of change of Expanded Disability Status Scale (EDSS) and change of 25-Foot-Walk-Test (25FWT) performed at home	Correlation of change of EDSS (range from 0.0 to 10.0, Lower scores mean a better outcome.) and change of time to execute 25FWT in seconds performed at home	day 1 and day 14
Secondary	Correlation of change of Expanded Disability Status Scale (EDSS) and change of 25-Foot-Walk-Test (25FWT) performed at clinic	Correlation of change of EDSS (range from 0.0 to 10.0, Lower scores mean a better outcome.) and change of time to execute 25FWT in seconds performed at clinic	day 1 and day 14