At-Home Gait Assessment

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT05724901
• Lead Sponsor: NYU Langone Health

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 \[last remote visit only\]).

Study Timeline

• Study Start: 2023-01-11
• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-13
• Status Verified: 2024-01
• Primary Completion: 2024-01-04
• Study Completion: 2024-01-04
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Gait Velocity	Up to Week 4	Measured using sensor-based gait assessment

Secondary Outcome Measures

Name	Time	Method
Mean Stance Duration	Up to Week 4	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.
Mean Double Support Duration	Up to Week 4	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.
Mean Stride Length	Up to Week 4	Measured using sensor-based gait assessment at baseline and remote visits 1, 2 and 3.
Mean Cadence	Up to Week 4	Cadence defined as number of steps per minute. Measured using sensor-based gait assessment at baseline and remote visits 1, 2 and 3.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States