NCT05724901
Completed
Not Applicable
A Wearable Remote Data Capture Solution for Home-Based Gait Assessment in Multiple Sclerosis
ConditionsMultiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- NYU Langone Health
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Mean Gait Velocity
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
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 \[last remote visit only\]).
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Mean Gait Velocity
Time Frame: Up to Week 4
Measured using sensor-based gait assessment
Secondary Outcomes
- Mean Double Support Duration(Up to Week 4)
- Mean Cadence(Up to Week 4)
- Mean Stride Length(Up to Week 4)
- Mean Stance Duration(Up to Week 4)
Study Sites (1)
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