Multiple SclerosisNCT05724901
At-Home Gait Assessment
An observational study of Multiple Sclerosis, run by NYU Langone Health at 1 site in United States.
Trial summary
The goal of this study is to validate an MS Gait Remote Capture and Analysis (MS-GRCA) system based on wearable shoe-based motion sensors for home-based and repeatable gait assessments. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2023to 4 Jan 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults (ages 18-70) diagnosed with MS, any subtypes (Relapsing Remitting, Primary Progressive, or Secondary Progressive MS).
Who may be able to join
- Ages 18-70 years old (inclusive)
- Confirmed diagnosis of MS (any MS subtypes, Relapsing Remitting [RR], Primary Progressive [PP], or Secondary Progressive [SP])
- PDSS score from 0 to 5
- Stable and continuous access to internet at home
- Adequate home facilities (enough space, quiet and distraction free area)
- Ability to provide informed consent.
Who cannot join
- Below average estimated premorbid cognitive functioning (based on WRAT-4 reading recognition standard z-score < 85).
- Presence of severe cognitive impairment (based on SDMT age normative z-score < -3.0).
- Presence of primary neurological disorders other than MS or primary psychiatric disorder that would influence ability to complete assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Wearable Remote Data Capture Solution for Home-Based Gait Assessment in Multiple Sclerosis
The goal of this study is to validate an MS Gait Remote Capture and Analysis (MS-GRCA) system based on wearable shoe-based motion sensors for home-based and repeatable gait assessments.
Read the detailed description
This is a single-site observational longitudinal study to validate an MS Gait Remote Capture and Analysis system for home-based and repeatable gait assessments. The investigators will recruit 30 participants who will have an in-person baseline visit (informed consent, standard gait assessment, sensor-based gait assessment, self-reported questionnaires), followed by three remote visits (sensor-based gait assessment, SUS questionnaire [last remote visit only]).
- Conditions
- Multiple Sclerosis
- Keywords
- Gait Analysis, telehealth, sensor-based gait analysis, home-based
- 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 |
|---|---|---|
| Adults with MS | Participants will complete an in-clinic visit (self-reported outcome of MS disability, a standard walking clinical evaluation, and a sensor-based gait evaluation) and 3 remote supervised self-administered gait assessments using the MS-GRCA system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Gait Velocity
Measured using sensor-based gait assessment
Measured: Up to Week 4
Secondary outcomes (4)
Mean Stride Length
Measured using sensor-based gait assessment at baseline and remote visits 1, 2 and 3.
Measured: Up to Week 4
Mean Double Support Duration
Double support duration represents the time that both feet are on the ground while walking. Measured using sensor-based gait assessment at baseline and remote visits 1, 2 and 3.
Measured: Up to Week 4
Mean Stance Duration
Stance duration represents the duration of the time between heel strike and toe off of the same foot. Measured using sensor-based gait assessment at baseline and remote visits 1, 2 and 3.
Measured: Up to Week 4
Mean Cadence
Cadence defined as number of steps per minute. Measured using sensor-based gait assessment at baseline and remote visits 1, 2 and 3.
Measured: Up to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start11 Jan 2023
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
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.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Leigh Charvet, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724901
- Sponsor's protocol ID
- 22-00375
- Status last verified
- Jan 2024
- First submitted
- 3 Feb 2023
- Last updated
- 17 Jan 2024
- 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 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Wearable Remote Data Capture Solution for Home-Based Gait Assessment in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05724901
- Acronym / sponsor ID
- 22-00375
- Conditions
- Multiple Sclerosis
- Keywords
- Gait Analysis, telehealth, sensor-based gait analysis, home-based
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 13 Feb 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.
The goal of this study is to validate an MS Gait Remote Capture and Analysis (MS-GRCA) system based on wearable shoe-based motion sensors for home-based and repeatable gait assessments.
Detailed description
This is a single-site observational longitudinal study to validate an MS Gait Remote Capture and Analysis system for home-based and repeatable gait assessments. The investigators will recruit 30 participants who will have an in-person baseline visit (informed consent, standard gait assessment, sensor-based gait assessment, self-reported questionnaires), followed by three remote visits (sensor-based gait assessment, SUS questionnaire [last remote visit only]).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with MS | – | –Participants will complete an in-clinic visit (self-reported outcome of MS disability, a standard walking clinical evaluation, and a sensor-based gait evaluation) and 3 remote supervised self-administered gait assessments using the MS-GRCA system. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (ages 18-70) diagnosed with MS, any subtypes (Relapsing Remitting, Primary Progressive, or Secondary Progressive MS).
Key inclusion criteria (6 listed)
- Ages 18-70 years old (inclusive)
- Confirmed diagnosis of MS (any MS subtypes, Relapsing Remitting [RR], Primary Progressive [PP], or Secondary Progressive [SP])
- PDSS score from 0 to 5
- Stable and continuous access to internet at home
- Adequate home facilities (enough space, quiet and distraction free area)
Key exclusion criteria (3 listed)
- Below average estimated premorbid cognitive functioning (based on WRAT-4 reading recognition standard z-score < 85).
- Presence of severe cognitive impairment (based on SDMT age normative z-score < -3.0).
- Presence of primary neurological disorders other than MS or primary psychiatric disorder that would influence ability to complete assessments.
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
Mean Gait Velocity
Time frame: Up to Week 4
Measured using sensor-based gait assessment
4 secondary outcomes
Mean Stride Length
Time frame: Up to Week 4
Mean Double Support Duration
Time frame: Up to Week 4
Mean Stance Duration
Time frame: Up to Week 4
Mean Cadence
Time frame: Up to Week 4
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 17 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
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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.
Leigh Charvet, PhD principal investigator
NYU Langone Health
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 NYU Langone Health at 1 site in United States.
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 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 17 Jan 2024. 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 United States. 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?
Mean Gait Velocity (time frame: Up to Week 4). 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 17 Jan 2024; AzTrials last refreshed its copy on 3 Nov 2026.