Multiple SclerosisNCT05781113
A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Condition
An observational study of Multiple Sclerosis, run by Celestra Health Systems at 3 sites in 3 countries.
Trial summary
To measure the effectiveness of a Remote Patient Monitoring solution based on the use of a smart insole wearable device (and associated smart phone app), for monitoring MS patients' condition on a day-to-day basis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 90 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Jul 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- Adult
Study population: The study population consists of 90 PwMS equally spread across 3 sites / geographies, with approximately 10% of patients in the EDSS 0 to 2.5 range, 45% of patients in EDSS range 3-4.5 and 45% of patients in EDSS range 5 to 6.5 (some patients within this latter group will use walking supports in the form of AFOs, electronic foot braces, etc.).
Who may be able to join
- Participants must have a diagnosis of Multiple Sclerosis (MS) based on the McDonald criteria, within an age range of 18 to 60.
- The participant must have an Extended Disability Status Scale (EDSS) score at screening less than or equal to 6.5, inclusive.
- The participant cohort will include at least 3 participants at each site exhibiting one of the following gait phenotypes: ataxic, hemiplegic and spastic. (Some participants may exhibit more than one phenotype).
- The participant cohort will include at least 3 participants at each site with a progressive form of MS.
Who cannot join
- Participants that are currently suffering from a musculoskeletal injury (e.g., sprain, fracture, strain, etc.) that limits their ability to use their full range of motion of any joint at the time of recruitment.
- Inability to provide informed consent.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Disease Condition Through Home Monitoring of MS Patients
To measure the effectiveness of a Remote Patient Monitoring solution based on the use of a smart insole wearable device (and associated smart phone app), for monitoring MS patients' condition on a day-to-day basis. The main focus is the objective measurement of gait, given that 75% of people with MS display clinically significant gait impairments. Initial gait lab "gold standard" data indicate that the Artificial Intelligence (AI)-based digital biomarker will prove to be highly effective at detecting changes in the MS patient's condition.
Read the detailed description
Multiple sclerosis (MS) is lifelong autoimmune disease that is typically first diagnosed in young adults; MS affects the central nervous system and can result in various impairments, including walking, cognition, dexterity, sleep, vision and bladder control. Notably, impairments to gait are the most common and are identified as the most impactful to a person with MS's (PwMS's) quality of life. Furthermore, ambulation is a key metric used to assess the severity of MS and is the basis for the Expanded Disability Status Scale (EDSS) that represents the global standard for assessing a patient's MS condition. For these reasons, clinicians employ a variety of gait tests to assess the severity and progression of the disease, which require frequent clinical visits and lack objective measurements as compared to what can be measured in a laboratory setting. Current scales do not detect subtle progression that could be indicative of early transformation into Secondary Progressive MS (SPMS) from Relapsing Remitting MS (RRMS) or significant progression in progressive forms of MS.
With advancements in wearable technologies and Artificial Intelligence (AI)-based algorithm development, clinicians can be provided with meaningful laboratory grade gait metrics collected in the patient's home environment to assist their practice. Objective walking information can be provided to clinicians to track the personalized progression of the disease to enable a more targeted treatment plan. A subset of this data is also shared with the patients via their smart phone app to keep them informed and motivated.
Several times per week, smart insoles in the patient's shoes will collect data from the embedded sensors (pressure sensors, accelerometer, gyroscope). The wearable smart insoles are fitted into a pair of the patient's "everyday use" shoes, and are very similar to the type of "comfort" insoles available from a local pharmacy. The smart insole data will be used to create AI-based personalized models that compute each individual's walking signature; this includes tracking of subtle changes over time (improvement, deterioration) as well as identifying specific gait phenotypes.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Adherence
To measure participant adherence, with respect to the wearable smart insoles and the associated smart phone app, for the purpose of MS disease monitoring. Adherence is defined as the collection by the participant of 15-minute walking samples 3x per week using the smart insoles and the associated smart phone app. Adherence will be assessed by calculating the number of tasks completed divided by the number of tasks prompted. > 80% is deemed high adherence.
Measured: 6 months
Clinician Acceptance
To measure clinician acceptance of the solution, by confirming that the results are readily interpretable and useful to the clinician. Specifically, we will measure the satisfaction of clinicians using a 5-point Likert scale, as follows: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, and Very dissatisfied.
Measured: 6 months
Secondary outcomes (3)
Gait Quality Measurement
To measure the MS participant's gait quality over a 6-month period under free-living conditions. This includes the detection and measurement of gait stability, gait improvements and gait deterioration. Gait quality is a composite score comprised of a weighted set of standard gait metrics, based on a scale of 0 to 100, with 100 representing perfect gait representative of a healthy individual, and 0 representing the worst score. For each walking sample, a composite gait quality score will be calculated. Standard gait metrics include: (1) temporal metrics such as Step Duration and Single Support Time, (2) spatial metrics such as Stride Length and Step Height and (3) spatiotemporal metrics such as Stride Velocity and Swing Velocity.
Measured: 6 months
Correlation between AI Gait Algorithms and Patience Perceptions
To correlate gait changes perceived by the Artificial Intelligence (AI)-based gait algorithms with participant perception of gait stability, improvement or worsening.
Measured: 6 months
AI-based Identification of Gait Phenotypes
To assess the accuracy of the AI-based algorithms for identifying specific gait phenotypes that are common within the MS patient population, including ataxic, hemiplegic and spastic gait patterns.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Jul 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celestra Health Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Ottawa, Barts & The London NHS Trust, The Ottawa Hospital, Brigham and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- Gauruv Bose, Dr., Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781113
- Sponsor's protocol ID
- CelestraHealthmct1
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share Individual Participant Data (IPD) with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Disease Condition Through Home Monitoring of MS Patients
- ClinicalTrials.gov ID
- NCT05781113
- Acronym / sponsor ID
- CelestraHealthmct1
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Celestra Health SystemsIndustry (pharma, biotech, devices)
- Collaborators
- University of Ottawa, Barts & The London NHS Trust, The Ottawa Hospital, Brigham and Women's Hospital
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Mar 2023 (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.
To measure the effectiveness of a Remote Patient Monitoring solution based on the use of a smart insole wearable device (and associated smart phone app), for monitoring MS patients' condition on a day-to-day basis. The main focus is the objective measurement of gait, given that 75% of people with MS display clinically significant gait impairments. Initial gait lab "gold standard" data indicate that the Artificial Intelligence (AI)-based digital biomarker will prove to be highly effective at detecting changes in the MS patient's condition.
Detailed description
Multiple sclerosis (MS) is lifelong autoimmune disease that is typically first diagnosed in young adults; MS affects the central nervous system and can result in various impairments, including walking, cognition, dexterity, sleep, vision and bladder control. Notably, impairments to gait are the most common and are identified as the most impactful to a person with MS's (PwMS's) quality of life. Furthermore, ambulation is a key metric used to assess the severity of MS and is the basis for the Expanded Disability Status Scale (EDSS) that represents the global standard for assessing a patient's MS condition. For these reasons, clinicians employ a variety of gait tests to assess the severity and progression of the disease, which require frequent clinical visits and lack objective measurements as compared to what can be measured in a laboratory setting. Current scales do not detect subtle progression that could be indicative of early transformation into Secondary Progressive MS (SPMS) from Relapsing Remitting MS (RRMS) or significant progression in progressive forms of MS.
With advancements in wearable technologies and Artificial Intelligence (AI)-based algorithm development, clinicians can be provided with meaningful laboratory grade gait metrics collected in the patient's home environment to assist their practice. Objective walking information can be provided to clinicians to track the personalized progression of the disease to enable a more targeted treatment plan. A subset of this data is also shared with the patients via their smart phone app to keep them informed and motivated.
Several times per week, smart insoles in the patient's shoes will collect data from the embedded sensors (pressure sensors, accelerometer, gyroscope). The wearable smart insoles are fitted into a pair of the patient's "everyday use" shoes, and are very similar to the type of "comfort" insoles available from a local pharmacy. The smart insole data will be used to create AI-based personalized models that compute each individual's walking signature; this includes tracking of subtle changes over time (improvement, deterioration) as well as identifying specific gait phenotypes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- The study population consists of 90 PwMS equally spread across 3 sites / geographies, with approximately 10% of patients in the EDSS 0 to 2.5 range, 45% of patients in EDSS range 3-4.5 and 45% of patients in EDSS range 5 to 6.5 (some patients within this latter group will use walking supports in the form of AFOs, electronic foot braces, etc.).
Key inclusion criteria (4 listed)
- Participants must have a diagnosis of Multiple Sclerosis (MS) based on the McDonald criteria, within an age range of 18 to 60.
- The participant must have an Extended Disability Status Scale (EDSS) score at screening less than or equal to 6.5, inclusive.
- The participant cohort will include at least 3 participants at each site exhibiting one of the following gait phenotypes: ataxic, hemiplegic and spastic. (Some participants may exhibit more than one phenotype).
- The participant cohort will include at least 3 participants at each site with a progressive form of MS.
Key exclusion criteria (2 listed)
- Participants that are currently suffering from a musculoskeletal injury (e.g., sprain, fracture, strain, etc.) that limits their ability to use their full range of motion of any joint at the time of recruitment.
- Inability to provide informed consent.
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
Participant Adherence
Time frame: 6 months
To measure participant adherence, with respect to the wearable smart insoles and the associated smart phone app, for the purpose of MS disease monitoring. Adherence is defined as the collection by the participant of 15-minute walking samples 3x per week using the smart insoles and the associated smart phone app. Adherence will be assessed by calculating the number of tasks completed divided by the number of tasks prompted. > 80% is deemed high adherence.
Clinician Acceptance
Time frame: 6 months
To measure clinician acceptance of the solution, by confirming that the results are readily interpretable and useful to the clinician. Specifically, we will measure the satisfaction of clinicians using a 5-point Likert scale, as follows: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, and Very dissatisfied.
3 secondary outcomes
Gait Quality Measurement
Time frame: 6 months
Correlation between AI Gait Algorithms and Patience Perceptions
Time frame: 6 months
AI-based Identification of Gait Phenotypes
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No. There is no plan to share Individual Participant Data (IPD) with other researchers.
Related trials for Multiple Sclerosis
Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
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RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis, Multiple Sclerosis
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis
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.
Gauruv Bose, Dr. principal investigator
The Ottawa Hospital
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Celestra Health Systems at 3 sites in 3 countries.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Participant Adherence (time frame: 6 months). The study lists 2 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 20 Mar 2026.