Validation of Smart Garments for Gait Classification

Healthy Clinical Trial

Official title:

Validation of Smart Garments for Gait and Balance Assessment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05898555
• Other study ID #: Myant/Waterloo/42689
• Status: Recruiting
• Start date: May 26, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Myant Medical Corp.
• Contact: James Tung, PhD
• Phone: 5198200619
• Email: james.tung[@]uwaterloo.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Waterloo - Engineering 7	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Myant Medical Corp.	University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.