At-Home Gait Assessment

Study Overview
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Brief Summary
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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
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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]).

Official Title
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A Wearable Remote Data Capture Solution for Home-Based Gait Assessment in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults with MS<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Gait Velocity | Measured using sensor-based gait assessment | Up to Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Stride Length | Measured using sensor-based gait assessment at baseline and remote visits 1, 2 and 3. | 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. | 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. | 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. | Up to Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait Analysis, telehealth, sensor-based gait analysis, home-based