Validation of Smart Garments for Gait Classification

Validation of Smart Garments for Gait and Balance Assessment

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Device: Skiin garment and pods

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: James Tung, PhD; Phone Number: 5198200619; Email: james.tung@uwaterloo.ca
• Study Contact Backup: Name: Bastien Moineau, PhD; Phone Number: 4166054570; Email: bastien.moineau@myant.ca

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L3G1
      • Recruiting
      • University of Waterloo - Engineering 7
      • Contact: James Tung, PhD; Phone Number: 5198200619; Email: james.tung@uwaterloo.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

A convenience-sample of 20 healthy individuals will be recruited for this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Healthy individuals; Gait study protocol

Device: Skiin garment and pods; Participants will be asked to wear a Skiin smart garment over their own clothes. Small motion capture markers will be placed on their body and pressure-sensitive insoles placed into their shoes to measure the pressure underneath their feet during the study tasks. Once the sensors are ready for collection, participants will be asked to complete 5 tasks associated with their daily activities: 1. Locomotion; 2. Lower limb strength - repeated sit-to-stand-to-sit transitions; 3. Lower limb strength and locomotion - Timed Up and Go; 4. Free walking during a 2min walk; 5. Standing balance, postural control.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Myant Medical Corp.
• Collaborators: University of Waterloo
• Investigators: Principal Investigator: James Tung, PhD, University of Waterloo

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Gait analysis; Wearable electronic devices
• Other Study ID Numbers: Myant/Waterloo/42689

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No