At-Home Gait Assessment

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults (ages 18-70) diagnosed with MS, any subtypes (Relapsing Remitting, Primary Progressive, or Secondary Progressive MS).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Leigh Charvet, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Actual): January 4, 2024
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Gait Analysis; telehealth; home-based; sensor-based gait analysis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 22-00375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No