Validation of Smart Garments for Gait Classification

Recruiting

• Conditions: Healthy
• Interventions: Device: Skiin garment and pods

• Registration Number: NCT05898555
• Lead Sponsor: Myant Medical Corp.

Brief Summary

The aim of this study is therefore to validate Myant SKIIN garments for the purpose of gait and balance assessment. To achieve this, we recruit young healthy adults from the University of Waterloo to wear Skiin products (see Fig. 1). Participants will be asked to perform a number of scripted gait and balance tasks.

Detailed Description

Specific objectives of this study are:

1. To validate Skiin gait characterization algorithm (based on single garment solutions - already developed based on a literature and a previous study conducted at the University of Waterloo);

2. To develop algorithms for multi-garments solutions that aim to extract additional kinematic parameters such as joint angles.

Gait metrics from Skiin garments will be compared to metrics from a gold standard measurement (Vicon motion capture) to indicate accuracy, precision and reliability.

Study Timeline

• Study Start: 2023-05-26
• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-01
• Study First Posted: 2023-06-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-05-01
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Healthy male and female adults aged 18y - 64y old

Exclusion Criteria

• Self-reported lower limb conditions, neurological disorders, history of concussion/brain trauma, and/or condition limiting exercise is to mitigate additional risk for injury and/or adverse reactions associated with exercise.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy individuals	Skiin garment and pods	Gait study protocol

Primary Outcome Measures

Name	Time	Method
Error in terminal double support (s) metric, and its asymmetry	Collection during the single study session of 1.5 hours.	The difference between terminal double support (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks.
Error in mean CoM sway velocity	Collection during the single study session of 1.5 hours.	The difference between sway velocity of the Center of mass calculated from Skiin data and from Vicon data for each scripted balance tasks.
Error in step length metric	Collection during the single study session of 1.5 hours.	The difference between step lengths calculated from Skiin data and from Vicon data for each scripted gait tasks.
Error in stance duration (s) metric, and its asymmetry	Collection during the single study session of 1.5 hours.	The difference between stance duration (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks.
Error in single limb support (s) metric, and its asymmetry	Collection during the single study session of 1.5 hours.	The difference between single limb support (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks.
Error in initial double support (s) metric, and its asymmetry	Collection during the single study session of 1.5 hours.	The difference between double support (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks.
Error in stride speed metric	Collection during the single study session of 1.5 hours.	The difference between stride speed calculated from Skiin data and from Vicon data for each scripted gait tasks.
Error in double support (s) metric, and its asymmetry	Collection during the single study session of 1.5 hours.	The difference between double support (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks.
Error in mean CoM sway distance	Collection during the single study session of 1.5 hours.	The difference between sway distance of the Center of mass calculated from Skiin data and from Vicon data for each scripted balance tasks.
Error in CoM sway area	Collection during the single study session of 1.5 hours.	The difference between sway area of the Center of mass calculated from Skiin data and from Vicon data for each scripted balance tasks.
Error in CoM sway frequency	Collection during the single study session of 1.5 hours.	The difference between sway frequency of the Center of mass calculated from Skiin data and from Vicon data for each scripted balance tasks.
Error in stride length metric	Collection during the single study session of 1.5 hours.	The difference between stride length calculated from Skiin data and from Vicon data for each scripted gait tasks.
Error in cadence metric	Collection during the single study session of 1.5 hours.	The difference between cadence calculated from Skiin data and from Vicon data for each scripted gait tasks.
Error in step duration (s) metric, and its asymmetry	Collection during the single study session of 1.5 hours.	The difference between step duration (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks.
Error in stride duration (s) metric, and its asymmetry	Collection during the single study session of 1.5 hours.	The difference between stride duration (s), and its asymmetry calculated from Skiin data for each scripted gait tasks.
Error in swing duration (s) metric, and its asymmetry	Collection during the single study session of 1.5 hours.	The difference between swing duration(s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks.
Error in gait speed metric	Collection during the single study session of 1.5 hours.	The difference between gait speed calculated from Skiin data and from Vicon data for each scripted gait tasks.

Trial Locations

Locations (1)

University of Waterloo - Engineering 7; 🇨🇦 Waterloo, Ontario, Canada