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Completed

NCT Number: NCT05724901

At-Home Gait Assessment

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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]).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mean Gait Velocity

    Time frame: Up to Week 4

    Measured using sensor-based gait assessment

Secondary outcomes

  1. Mean Stride Length

    Time frame: Up to Week 4

    Measured using sensor-based gait assessment at baseline and remote visits 1, 2 and 3.

  2. Mean Double Support Duration

    Time frame: 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.

  3. Mean Stance Duration

    Time frame: 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.

  4. Mean Cadence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2023
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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