Clinical trial NCT05898555: Validation of Smart Garments for Gait Classification
Official title: Validation of Smart Garments for Gait and Balance Assessment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Keywords: Gait analysis
Wearable electronic devices
Lead sponsor: Myant Medical Corp.
Sponsor class: INDUSTRY
Collaborators: name: University of Waterloo
First posted: 2023-06-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A convenience-sample of 20 healthy individuals will be recruited for this study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Error in step length metric
timeFrame: Collection during the single study session of 1.5 hours.
measure: Error in stride length metric
timeFrame: Collection during the single study session of 1.5 hours.
measure: Error in cadence metric
timeFrame: Collection during the single study session of 1.5 hours.
measure: Error in step duration (s) metric, and its asymmetry
timeFrame: Collection during the single study session of 1.5 hours.
measure: Error in stride duration (s) metric, and its asymmetry
timeFrame: Collection during the single study session of 1.5 hours.
measure: Error in stance duration (s) metric, and its asymmetry
timeFrame: Collection during the single study session of 1.5 hours.
measure: Error in swing duration (s) metric, and its asymmetry
timeFrame: Collection during the single study session of 1.5 hours.
measure: Error in initial double support (s) metric, and its asymmetry
timeFrame: Collection during the single study session of 1.5 hours.
measure: Error in terminal double support (s) metric, and its asymmetry
timeFrame: Collection during the single study session of 1.5 hours.
measure: Error in double support (s) metric, and its asymmetry
timeFrame: Collection during the single study session of 1.5 hours.
measure: Error in single limb support (s) metric, and its asymmetry
timeFrame: Collection during the single study session of 1.5 hours.
measure: Error in gait speed metric
timeFrame: Collection during the single study session of 1.5 hours.
measure: Error in stride speed metric
timeFrame: Collection during the single study session of 1.5 hours.
measure: Error in mean CoM sway distance
timeFrame: Collection during the single study session of 1.5 hours.
measure: Error in mean CoM sway velocity
timeFrame: Collection during the single study session of 1.5 hours.
measure: Error in CoM sway area
timeFrame: Collection during the single study session of 1.5 hours.
measure: Error in CoM sway frequency
timeFrame: Collection during the single study session of 1.5 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo - Engineering 7
state: Ontario
Study officials:
affiliation: University of Waterloo
name: James Tung, PhD
role: PRINCIPAL_INVESTIGATOR
References: