Multiple SclerosisMSgoesHomeNCT04771858
Digital Gait Analysis in the Home Environment of Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Medical Valley Digital Health Application Center GmbH at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 9 Mar 2021to 28 Jun 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients are recruited at the University Hospital Regensburg via the routine university outpatient clinic of the Department and Polyclinic of Neurology.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, University of Regensburg
Regensburg, Bavaria, 93053
About this study
Official title: MSgoesHome - Digital Gait Analysis in the Home Environment of Patients With Multiple Sclerosis
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.
Read more
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
- Medical subject headings
- Multiple Sclerosis
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 | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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%)
Measured: 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%)
Measured: 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.)
Measured: 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
Difference in time, measured in seconds, of 25FWT performed at home and performed at clinic
Measured: day 1
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
Measured: day 14
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
Measured: day 1
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
Measured: day 14
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
Measured: day 1 and day 14
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
Measured: day 1 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start9 Mar 2021
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Valley Digital Health Application Center GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation, NeuroSys GmbH, Fraunhofer Institute for Integrated Circuits IIS, Portabiles HealthCare Technologies GmbH, University of Regensburg
- Responsible party
- Sponsor
- Investigators
- Ralf Linker, Professor, Principal investigator, Department of Neurology, University of Regensburg, Regensburg 93053, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771858
- Sponsor's protocol ID
- MV-dmac 3445707
- Acronym
- MSgoesHome
- Status last verified
- Jun 2023
- First submitted
- 2 Feb 2021
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MSgoesHome - Digital Gait Analysis in the Home Environment of Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04771858
- Acronym / sponsor ID
- MSgoesHome / MV-dmac 3445707
- Conditions
- Multiple Sclerosis
- Keywords
- Gait Analysis, Home-Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical Valley Digital Health Application Center GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation, NeuroSys GmbH, Fraunhofer Institute for Integrated Circuits IIS, Portabiles HealthCare Technologies GmbH, University of Regensburg
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 25 Feb 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.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited at the University Hospital Regensburg via the routine university outpatient clinic of the Department and Polyclinic of Neurology.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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
Number of detected gait cycles per patient per day
Time frame: day 1 to day 14
Number of sensor-detected gait cycles (one gait cycle are two steps) per patient per day
Daily sensor wear time per patient
Time frame: day 1 to day 14
Percentage of sensor wear time per patient per day - range from 0 hours (0%) to 6 hours (100%)
Completeness of days during 14-day field period per patient with sensor records
Time frame: day 1 to day 14
Percentage of days with sensor data recorded per patient - range from 0 days (0%) to 14 days (100%)
System Usability Scale (SUS)
Time frame: day 14 (closeout visit)
SUS score per patient - range from 0 to 100 score points (Higher scores mean a better outcome.)
6 secondary outcomes
Difference in time of 25-Foot-Walk-Test (25FWT) performed at home versus 25-Foot-Walk-Test (25FWT) performed at clinic
Time frame: day 1
Difference in time of 25-Foot-Walk-Test (25FWT) performed at home versus 25-Foot-Walk-Test (25FWT) performed at clinic
Time frame: day 14
Difference in gait parameters during 25-Foot-Walk-Test (25FWT) performed at home versus 25-Foot-Walk-Test (25FWT) performed at clinic
Time frame: day 1
Difference in gait parameters during 25-Foot-Walk-Test (25FWT) performed at home versus 25-Foot-Walk-Test (25FWT) performed at clinic
Time frame: day 14
Correlation of change of Expanded Disability Status Scale (EDSS) and change of 25-Foot-Walk-Test (25FWT) performed at home
Time frame: day 1 and day 14
Correlation of change of Expanded Disability Status Scale (EDSS) and change of 25-Foot-Walk-Test (25FWT) performed at clinic
Time frame: day 1 and day 14
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 3 Jul 2023.
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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.
Ralf Linker, Professor principal investigator
Department of Neurology, University of Regensburg, Regensburg 93053, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Medical Valley Digital Health Application Center GmbH at 1 site 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 6 inclusion and 5 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of detected gait cycles per patient per day (time frame: day 1 to day 14). The study lists 4 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 3 Jul 2023.