At-Home Gait Assessment

NCT05724901 | Completed

• 1 other identifier: 22-00375
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Gait Analysis; telehealth; sensor-based gait analysis; home-based

Outcome Measures

Primary Outcomes (1)

• Mean Gait Velocity

  Measured using sensor-based gait assessment

  Up to Week 4

Secondary Outcomes (4)

• Mean Stride Length

  Up to Week 4

• Mean Double Support Duration

  Up to Week 4

• Mean Stance Duration

  Up to Week 4

• Mean Cadence

  Up to Week 4

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• United States Department of Defense: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Leigh Charvet, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 13, 2023
• Study Start: January 11, 2023
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)