At-Home Gait Assessment

NCT ID: NCT05724901

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-11

Study Completion Date

2024-01-04

Brief Summary

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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

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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 \[last remote visit only\]).

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leigh Charvet, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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22-00375

Identifier Type: -

Identifier Source: org_study_id

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