At-Home Gait Assessment | NCT05724901

Studies
At-Home Gait Assessment

NCT05724901

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Jan 17, 2024Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 2023Actual

Primary Completion Date

Jan 4, 2024Actual

Completion Date

Jan 4, 2024Actual

First Submitted Date

Feb 3, 2023

First Submission Date that Met QC Criteria

Feb 10, 2023

First Posted Date

Feb 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2024

Last Update Posted Date

Jan 17, 2024Actual

Name	Class
United States Department of Defense	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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]).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Gait Velocity	Measured using sensor-based gait assessment	Up to Week 4

Secondary Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leigh Charvet, PhD	NYU Langone Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NYU Langone Health		New York	New York	10016	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Jan 10, 2023	Jan 12, 2024	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided