Multiple Sclerosis, Relapsing-RemittingMOTOSENSNCT04993274
Sensitivity of Motor Assessment in MS - a Prospective Cohort Study
An observational study of Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis, Secondary Progressive, run by Friedemann Paul at 1 site in Germany.
Trial summary
The study explores the application of marker-less motion analysis (visual-perceptive computing, VPC) using a consumer grade infrared and video camera (Microsoft Kinect) for clinical assessment in MS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis, Chronic Progressive
- What is being tested?
- PASS-MS
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 20 Feb 2019to Nov 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: We aim to include and follow-up 100 patients with a diagnosis of MS according to revised McDonald criteria including relapsing-remitting and progressive disease courses. The design as a single-center study implied that broad inclusion criteria (RRMS, SPMS, PPMS) should be used in order to obtain robust results. We therefore chose not to limit recruitment to progressive MS, which would have required a multi-center study. Still, we conceive the main results of our study - sensitivity and responsiveness - to be conferrable to progressive MS (yet not the progression rates). We restrict inclusion to those able to walk at least short distance with unilateral assistance according to the testing requirements of the primary outcome. We further include patients with any intervention for MS or other morbidity as long as this is not considered to affect balance or locomotor function. Type of MS treatment and comorbidities are documented at baseline and follow-up.
Who may be able to join
- diagnosis of multiple sclerosis (relapsing-remitting, secondary or primary chronic progressive)
- ability to perform PASS-MS short walking test (max. of 5 m distance) with no or only unilateral assistance (EDSS <6.5)
- written consent
Who cannot join
- Inability to understand/ follow test instructions for any reason
- Other cause of locomotor or balance dysfunction than MS
Trial locations and contacts
1 site in 1 country.
Germany1 site
Experimental and Clinical Research Center, Studienambulanz Neuroimmunologie am Standort NCRC, Campus Mitte,Charité - Universitätsmedizin Berlin
Berlin, 10117
About this study
Official title: Sensitivity of Quantitative Motor Performance Measures in Multiple Sclerosis - a Prospective Cohort Study Over Two Years Using Microsoft Kinect
The study explores the application of marker-less motion analysis (visual-perceptive computing, VPC) using a consumer grade infrared and video camera (Microsoft Kinect) for clinical assessment in MS. It includes as the primary outcomes a short assessment battery of simple motor tasks (PASS-MS) that can be performed in front of the sensor after standard oral instructions given by the operator. For each task, the sensor data are transformed into a set of kinematic parameters that may be used as motor outcome reflecting specific neurological dysfunction. For validation against both clinical and patient-reported outcomes as well as MRI findings, we here prospectively investigate a large cohort of patients with multiple sclerosis. This will allow to determine the usefulness of the various kinematic parameters generated and to define a reduced set of the most meaningful parameters for potential use in future MS trials. Data on repeatability and benchmarks for clinically relevant change are essential to interpret test results and, more importantly, changes thereof. Further, this prospective study will yield estimates of progression rates that are required for planning future studies using this motion analysis tool and assessment battery as an outcome. The study is designed to obtain benchmarks for sensitivity and clinical responsiveness. Primary analysis aims to answer the question: Does the SMSW - Maximum Speed worsen with disease progression established as confirmed disability progression based on EDSS after 24 months (defined as 1 step increase in EDSS ≤ 5.5 and 0.5 step in EDSS > 5.5)?
Read the detailed description
The study is designed as a prospective observational (non-interventional) single-center study performed at one center, Charité - Universitätsmedizin Berlin.
This study converges with prospective observational studies performed at our center. These studies started in 2011 with the objective to define determinants of progression in neuroimmunological disorders (CIS, MS, NMO).
The variables collected for this study were defined according to the study objective and comprise different markers of motor/mobility function, cognitive and affective function, fatigue and health-related quality of life. The primary outcome is a VPC-based assessment of locomotor function (PASS-MS SMSW-MaxS) as the diagnostic test under study. Secondary outcomes serve to cross-validate progression rates or as benchmarks of clinical progression to determine clinical relevance of change. Further, possible effects of cognitive and affective function on the primary outcome can be explored which is of high relevance for the interpretation of changes in the population of MS.
All assessments are performed at inclusion and after 12and 24 months.
Primary outcome:
PASS-MS kinematic parameters with Short Maximum Speed Walk - Speed (SMSW-MaxS) as primary outcome
Secondary outcomes:
- Clinical Examination
- Other kinematic parameters derived from PASS-MS
- Clinical Rating with EDSS and Multiple Sclerosis Functional Composite (MSFC) consisting of tests of walking capacity (T25FW), hand dexterity (9HPT), cognitive processing speed (SDMT) and visual acuity (Sloan charts)
- Cognitive testing (BRB-N)
- Patient-reported outcomes on global impression of change, MS-related impairment in walking (MSWS-12), hand function, occurrence of fatigue (FSMC), depressive symptoms (BDI-II) and health-related quality of life by MS-specific questionnaire (HAQUAMS)
A change in T25FW speed of at least 20% was found to be clinically meaningful for MS patients (Hobart 2013). In a previous study the investigators found SMSW average walking speed was slower in MS patients (1.6 ± 0.3 m/sec) than in HC (1.8 ± 0.4 m/sec) (Behrens 2014). Therefore, a similar average walking speed was assumed for the population under study at baseline (1.6 m/sec) and a decrease of 0.3 m/sec (corresponding to approximately 20%) as clinically meaningful. Moreover, based on previous reports, investigators assume a standard deviation in the changes of SMSW-MaxS of 0.4 m/sec (Behrens 2014). This results in an expected effect size of 0.75 for the change in SMSW-MaxS between baseline and 24 months follow-up in those with clinically confirmed disability progression. A sample size of N=16 patients will have a power of 80% to detect an effect size of 0.75 with a two-sided significance level of 0.05 and a t-test for dependent samples (nQuery Advisor 7.0).
Sample size estimation considered previous evidence on the proportion of patients who will show clinically confirmed disability progression throughout the observation period based on an EDSS change defined as 1 step increase in EDSS ≤ 5.5 and 0.5 step in EDSS > 5.5 within 24 months. Cutter et al. (1999) reported that 10% of their patients showed EDSS confirmed sustained change within 3 months and 40% showed a change to baseline in 1 year reported in MSFC, which also incorporates the T25FW. The investigators assume that at least 20 % of patients showing a confirmed sustained change in EDSS according to above definition within 24months to be a realistic scenario.
When considering an overall dropout rate of 10-20% (lost to follow-up), this would result in N=16 complete datasets when overall N=100 patients are included.
Patients should not have had an acute relapse up to 3 months before follow-up visit (12 and 24 months). To avoid dropout due to acute relapse the follow-up visit is extended to up to 3 months in case of acute relapse.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis, Chronic Progressive
- Being tested
- PASS-MS
- Keywords
- multiple sclerosis, gait, balance, postural control, progression, observational, assessment, motion capture
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PASS-MSDiagnostic test
protocol using short motor tasks performed by the subject and recorded by a depth camera, motion analysis by visuo-perceptive computing
What is being measured
The primary outcome is the main question the study is designed to answer.
change in PASS-MS kinematic parameter Short Maximum Speed Walk - Speed (SMSW-MaxS)
walking speed calculated from short distance walking in the SMSW task
Measured: change from baseline value at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start20 Feb 2019
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friedemann Paul
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor-investigator, Friedemann Paul, Charite University, Berlin, Germany
- Investigators
- Friedemann Paul, Principal investigator, Experimental and Clinical Research Center, Charité - Universitätsmedizin Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993274
- Sponsor's protocol ID
- EA1/240/18
- Acronym
- MOTOSENS
- Status last verified
- Aug 2021
- First submitted
- 9 Mar 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ellinghaus CA, Rohling HM, Dorsch EM, Sperber PS, Arsenova R, Buenrostro GS, Rekers S, Usnich T, Schindler P, Kroneberg D, Bellmann-Strobl J, Oertel FC, Brandt AU, Weygandt M, Paul F, Piper SK, Schmitz-Hubsch T. Anchor-based evaluation of digital motor biomarkers from a 2-year observation in 100 patients with multiple sclerosis. J Neurol. 2025 Dec 4;273(1):4. doi: 10.1007/s00415-025-13541-y.
PubMed 41342942
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity of Quantitative Motor Performance Measures in Multiple Sclerosis - a Prospective Cohort Study Over Two Years Using Microsoft Kinect
- ClinicalTrials.gov ID
- NCT04993274
- Acronym / sponsor ID
- MOTOSENS / EA1/240/18
- Conditions
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis, Chronic Progressive
- Keywords
- multiple sclerosis, gait, balance, postural control, progression, observational, assessment, motion capture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Friedemann PaulUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 6 Aug 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 study explores the application of marker-less motion analysis (visual-perceptive computing, VPC) using a consumer grade infrared and video camera (Microsoft Kinect) for clinical assessment in MS. It includes as the primary outcomes a short assessment battery of simple motor tasks (PASS-MS) that can be performed in front of the sensor after standard oral instructions given by the operator. For each task, the sensor data are transformed into a set of kinematic parameters that may be used as motor outcome reflecting specific neurological dysfunction. For validation against both clinical and patient-reported outcomes as well as MRI findings, we here prospectively investigate a large cohort of patients with multiple sclerosis. This will allow to determine the usefulness of the various kinematic parameters generated and to define a reduced set of the most meaningful parameters for potential use in future MS trials. Data on repeatability and benchmarks for clinically relevant change are essential to interpret test results and, more importantly, changes thereof. Further, this prospective study will yield estimates of progression rates that are required for planning future studies using this motion analysis tool and assessment battery as an outcome. The study is designed to obtain benchmarks for sensitivity and clinical responsiveness. Primary analysis aims to answer the question: Does the SMSW - Maximum Speed worsen with disease progression established as confirmed disability progression based on EDSS after 24 months (defined as 1 step increase in EDSS ≤ 5.5 and 0.5 step in EDSS > 5.5)?
Detailed description
The study is designed as a prospective observational (non-interventional) single-center study performed at one center, Charité - Universitätsmedizin Berlin.
This study converges with prospective observational studies performed at our center. These studies started in 2011 with the objective to define determinants of progression in neuroimmunological disorders (CIS, MS, NMO).
The variables collected for this study were defined according to the study objective and comprise different markers of motor/mobility function, cognitive and affective function, fatigue and health-related quality of life. The primary outcome is a VPC-based assessment of locomotor function (PASS-MS SMSW-MaxS) as the diagnostic test under study. Secondary outcomes serve to cross-validate progression rates or as benchmarks of clinical progression to determine clinical relevance of change. Further, possible effects of cognitive and affective function on the primary outcome can be explored which is of high relevance for the interpretation of changes in the population of MS.
All assessments are performed at inclusion and after 12and 24 months.
Primary outcome:
PASS-MS kinematic parameters with Short Maximum Speed Walk - Speed (SMSW-MaxS) as primary outcome
Secondary outcomes:
- Clinical Examination
- Other kinematic parameters derived from PASS-MS
- Clinical Rating with EDSS and Multiple Sclerosis Functional Composite (MSFC) consisting of tests of walking capacity (T25FW), hand dexterity (9HPT), cognitive processing speed (SDMT) and visual acuity (Sloan charts)
- Cognitive testing (BRB-N)
- Patient-reported outcomes on global impression of change, MS-related impairment in walking (MSWS-12), hand function, occurrence of fatigue (FSMC), depressive symptoms (BDI-II) and health-related quality of life by MS-specific questionnaire (HAQUAMS)
A change in T25FW speed of at least 20% was found to be clinically meaningful for MS patients (Hobart 2013). In a previous study the investigators found SMSW average walking speed was slower in MS patients (1.6 ± 0.3 m/sec) than in HC (1.8 ± 0.4 m/sec) (Behrens 2014). Therefore, a similar average walking speed was assumed for the population under study at baseline (1.6 m/sec) and a decrease of 0.3 m/sec (corresponding to approximately 20%) as clinically meaningful. Moreover, based on previous reports, investigators assume a standard deviation in the changes of SMSW-MaxS of 0.4 m/sec (Behrens 2014). This results in an expected effect size of 0.75 for the change in SMSW-MaxS between baseline and 24 months follow-up in those with clinically confirmed disability progression. A sample size of N=16 patients will have a power of 80% to detect an effect size of 0.75 with a two-sided significance level of 0.05 and a t-test for dependent samples (nQuery Advisor 7.0).
Sample size estimation considered previous evidence on the proportion of patients who will show clinically confirmed disability progression throughout the observation period based on an EDSS change defined as 1 step increase in EDSS ≤ 5.5 and 0.5 step in EDSS > 5.5 within 24 months. Cutter et al. (1999) reported that 10% of their patients showed EDSS confirmed sustained change within 3 months and 40% showed a change to baseline in 1 year reported in MSFC, which also incorporates the T25FW. The investigators assume that at least 20 % of patients showing a confirmed sustained change in EDSS according to above definition within 24months to be a realistic scenario.
When considering an overall dropout rate of 10-20% (lost to follow-up), this would result in N=16 complete datasets when overall N=100 patients are included.
Patients should not have had an acute relapse up to 3 months before follow-up visit (12 and 24 months). To avoid dropout due to acute relapse the follow-up visit is extended to up to 3 months in case of acute relapse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We aim to include and follow-up 100 patients with a diagnosis of MS according to revised McDonald criteria including relapsing-remitting and progressive disease courses. The design as a single-center study implied that broad inclusion criteria (RRMS, SPMS, PPMS) should be used in order to obtain robust results. We therefore chose not to limit recruitment to progressive MS, which would have required a multi-center study. Still, we conceive the main results of our study - sensitivity and responsiveness - to be conferrable to progressive MS (yet not the progression rates). We restrict inclusion to those able to walk at least short distance with unilateral assistance according to the testing requirements of the primary outcome. We further include patients with any intervention for MS or other morbidity as long as this is not considered to affect balance or locomotor function. Type of MS treatment and comorbidities are documented at baseline and follow-up.
Key inclusion criteria (3 listed)
- diagnosis of multiple sclerosis (relapsing-remitting, secondary or primary chronic progressive)
- ability to perform PASS-MS short walking test (max. of 5 m distance) with no or only unilateral assistance (EDSS <6.5)
- written consent
Key exclusion criteria (2 listed)
- Inability to understand/ follow test instructions for any reason
- Other cause of locomotor or balance dysfunction than MS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PASS-MSprotocol using short motor tasks performed by the subject and recorded by a depth camera, motion analysis by visuo-perceptive computing | Diagnostic test | – |
Primary outcome
change in PASS-MS kinematic parameter Short Maximum Speed Walk - Speed (SMSW-MaxS)
Time frame: change from baseline value at 2 years
walking speed calculated from short distance walking in the SMSW task
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Derived from this study: PubMed 41342942Ellinghaus CA, Rohling HM, Dorsch EM, Sperber PS, Arsenova R, Buenrostro GS, Rekers S, Usnich T, Schindler P, Kroneberg D, Bellmann-Strobl J, Oertel FC, Brandt AU, Weygandt M, Paul F, Piper SK, Schmitz-Hubsch T. Anchor-based evaluation of digital motor biomarkers from a 2-year observation in 100 patients with multiple sclerosis. J Neurol. 2025 Dec 4;273(1):4. doi: 10.1007/s00415-025-13541-y.
- Individual participant dataSharing planned: No
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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.
Friedemann Paul principal investigator
Experimental and Clinical Research Center, Charité - Universitätsmedizin Berlin, 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, Relapsing-Remitting and Multiple Sclerosis, Secondary Progressive, run by Friedemann Paul 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Aug 2021. 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?
Results are not available in the source record.
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?
change in PASS-MS kinematic parameter Short Maximum Speed Walk - Speed (SMSW-MaxS) (time frame: change from baseline value at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04993274, which also lists 1 linked publication.
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 10 Aug 2021.