At-Home Gait Assessment

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05724901
• Other study ID #: 22-00375
• Status: Completed
• Start date: January 11, 2023
• Est. completion date: January 4, 2024

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 4, 2024
• Est. primary completion date: January 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Gait Velocity	Measured using sensor-based gait assessment	Up to Week 4
Secondary	Mean Stride Length	Measured using sensor-based gait assessment at baseline and remote visits 1, 2 and 3.	Up to Week 4
Secondary	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
Secondary	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
Secondary	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