Multiple SclerosiseMSGaitNCT04969848
Quantifying Gait Alteration in Multiple Sclerosis Using a Wearable Device
An observational study of Multiple Sclerosis, run by Nantes University Hospital at 1 site in France.
Trial summary
Gait alteration is frequent in MS and limitation in walking ability is a major concern in MS patients. The development of wearable device offers the opportunity to collect data during daily activity including walking. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Wearable sensor
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 18 Aug 2021to 31 May 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: MS patients cohort followed at Nantes university hospital
Who may be able to join
- Age 18 - 64 years
- Diagnosis of MS based on McDonald criteria (including Relapsing-remitting and progressive MS)
- No relapse within the last 5 weeks before recruitment
- Able to walk with or without assistance/help/aid (one or 2 canes)
- EDSS [0-6]
Who cannot join
- Women who are pregnant
- Patient having expressed their opposition
- Patient under guardianship or security measure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uncontrolled, Single-center Study to Quantify Gait Disturbance in Patients With Multiple Sclerosis
Gait alteration is frequent in MS and limitation in walking ability is a major concern in MS patients. The development of wearable device offers the opportunity to collect data during daily activity including walking.
Read the detailed description
Umanit and LMJ (Nantes university) has developed a device call eMSgait to assess walking ability in MS patients individuals (eg MS patients). This device consists in a commercialized IMU sensor (MetaMotionR Sensor, Mbientilab) worn at the right hip, a smartphone app and dedicated algorithm/mathematical model to extract raw sensor data and calculate individual gait pattern (IGP). This IGP consists of a curve, based on quaternion and representing the rotation recorded by the IMU during an average gait cycle. Pursue first pilot work assessing information from IGP on gait alteration in MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Wearable sensor
- Keywords
- Wearable sensor, Gait
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable sensorOther
Also called MetaMotionR Sensor, Mbientilab
IMU sensor (as part of eMSGait device) worn at the hip during T25FW
| Study group | Role | What they receive |
|---|---|---|
| eMSGait | Record of IGP using IMU sensor (Metamotion R mbientlab) during T25FW. Receives: Other: Wearable sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation with disability
Correlation of gait measures (mean amplitude of walking cycles (m), mean duration of walking cycles (s), Stance swing phase ratio) obtained during a walk of 25 feet with Expanded Disability Status Scale (EDSS). EDSS is an ordinal scale measuring disability and ranging from 0 (normal examination) to 10 (death due to MS) in a 0,5-point increments from score 1.
Measured: One time point per patient (inclusion)
Secondary outcomes (7)
Correlation with neurological function
Pyramidal, cerebellar and sensory functions are assessed with Kurtzke functional system scores which are based on neurological examination. Scores of the Pyramidal and sensory systems range from 0 (normal) to 6 . Cerebellar system scores range from 0 (normal) to 6. Cerebellar system scores range from 0 (normal) to 5
Measured: One time point per patient (inclusion)
Correlation with gait speed
Timed 25-Foot Walk (T25FW). T25FW measures the time needed to complete a 25-foot walk. Two trials are averaged
Measured: One time point per patient (inclusion)
Correlation with lateralization
Lower limb lateralization (right vs left)
Measured: One time point per patient (inclusion)
Correlation with disability location
Upper, lower limb, trunk MS symptoms location
Measured: One time point per patient (inclusion)
Correlation with MS symptoms severity
MS symptoms severity quote as none, mild moderate severe
Measured: One time point per patient (inclusion)
Reliability of sensor measures
Gait parameters record during a 25-foot walk repeated twice at 5 min apart.
Measured: At the inclusion
Developement of dedicated algorithm to improve signal processing from IMU.
Number of detected gait cycles during a foot walk.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start18 Aug 2021
- Primary completion31 May 2022
- Study completion31 May 2022
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
- Other
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969848
- Sponsor's protocol ID
- RC21_0070
- Acronym
- eMSGait
- Status last verified
- Jun 2022
- First submitted
- 28 May 2021
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncontrolled, Single-center Study to Quantify Gait Disturbance in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04969848
- Acronym / sponsor ID
- eMSGait / RC21_0070
- Conditions
- Multiple Sclerosis
- Keywords
- Wearable sensor, Gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 21 Jul 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.
Gait alteration is frequent in MS and limitation in walking ability is a major concern in MS patients. The development of wearable device offers the opportunity to collect data during daily activity including walking.
Detailed description
Umanit and LMJ (Nantes university) has developed a device call eMSgait to assess walking ability in MS patients individuals (eg MS patients). This device consists in a commercialized IMU sensor (MetaMotionR Sensor, Mbientilab) worn at the right hip, a smartphone app and dedicated algorithm/mathematical model to extract raw sensor data and calculate individual gait pattern (IGP). This IGP consists of a curve, based on quaternion and representing the rotation recorded by the IMU during an average gait cycle. Pursue first pilot work assessing information from IGP on gait alteration in MS.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eMSGait | – | Other: Wearable sensorRecord of IGP using IMU sensor (Metamotion R mbientlab) during T25FW. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- MS patients cohort followed at Nantes university hospital
Key inclusion criteria (5 listed)
- Age 18 - 64 years
- Diagnosis of MS based on McDonald criteria (including Relapsing-remitting and progressive MS)
- No relapse within the last 5 weeks before recruitment
- Able to walk with or without assistance/help/aid (one or 2 canes)
- EDSS [0-6]
Key exclusion criteria (3 listed)
- Women who are pregnant
- Patient having expressed their opposition
- Patient under guardianship or security measure
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 |
|---|---|---|
| Wearable sensorAlso: MetaMotionR Sensor, MbientilabIMU sensor (as part of eMSGait device) worn at the hip during T25FW | Other | eMSGait |
Primary outcome
Correlation with disability
Time frame: One time point per patient (inclusion)
Correlation of gait measures (mean amplitude of walking cycles (m), mean duration of walking cycles (s), Stance swing phase ratio) obtained during a walk of 25 feet with Expanded Disability Status Scale (EDSS). EDSS is an ordinal scale measuring disability and ranging from 0 (normal examination) to 10 (death due to MS) in a 0,5-point increments from score 1.
7 secondary outcomes
Correlation with neurological function
Time frame: One time point per patient (inclusion)
Correlation with gait speed
Time frame: One time point per patient (inclusion)
Correlation with lateralization
Time frame: One time point per patient (inclusion)
Correlation with disability location
Time frame: One time point per patient (inclusion)
Correlation with MS symptoms severity
Time frame: One time point per patient (inclusion)
Reliability of sensor measures
Time frame: At the inclusion
Developement of dedicated algorithm to improve signal processing from IMU.
Time frame: Day 1
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 Jun 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nantes University Hospital at 1 site in France.
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 5 inclusion and 3 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 Jun 2022. 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 France. 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?
Correlation with disability (time frame: One time point per patient (inclusion)). 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 Jun 2022.