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

NCT04771858 | Completed

• 1 other identifier: MV-dmac 3445707
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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?

Conditions

Multiple Sclerosis

Keywords

Gait Analysis; Home-Monitoring

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (6)

• Difference in time of 25-Foot-Walk-Test (25FWT) performed at home versus 25-Foot-Walk-Test (25FWT) performed at clinic

  day 1

• Difference in time of 25-Foot-Walk-Test (25FWT) performed at home versus 25-Foot-Walk-Test (25FWT) performed at clinic

  day 14

• Difference in gait parameters during 25-Foot-Walk-Test (25FWT) performed at home versus 25-Foot-Walk-Test (25FWT) performed at clinic

  day 1

• Difference in gait parameters during 25-Foot-Walk-Test (25FWT) performed at home versus 25-Foot-Walk-Test (25FWT) performed at clinic

  day 14

• Correlation of change of Expanded Disability Status Scale (EDSS) and change of 25-Foot-Walk-Test (25FWT) performed at home

  day 1 and day 14

Study Arms (1)

Study Group

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Valley Digital Health Application Center GmbH: lead
• Celgene Corporation: collaborator
• NeuroSys GmbH: collaborator
• Fraunhofer Institute for Integrated Circuits IIS: collaborator
• Portabiles HealthCare Technologies GmbH: collaborator
• University of Regensburg: collaborator

Study Sites (1)

Department of Neurology, University of Regensburg

Regensburg, Bavaria, 93053, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ralf Linker, Professor

  Department of Neurology, University of Regensburg, Regensburg 93053, Germany

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 25, 2021
• Study Start: March 9, 2021
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

DE (1)