At-Home Gait Assessment

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05724901

Enrollment

Registered

2023-02-13

Start date

2023-01-11

Completion date

2024-01-04

Last updated

2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

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

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 \[last remote visit only\]).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Mean Stride Length	Up to Week 4	Measured using sensor-based gait assessment at baseline and remote visits 1, 2 and 3.
Mean Double Support Duration	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.
Mean Stance Duration	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.
Mean Cadence	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.

Countries

United States

Outcome results