Validation of Smart Garments for Gait Classification

NCT ID: NCT05898555

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-26

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy individuals

Gait study protocol

Skiin garment and pods

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Waterloo

OTHER

Sponsor Role collaborator

Myant Medical Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Tung, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Locations

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University of Waterloo - Engineering 7

Waterloo, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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James Tung, PhD

Role: CONTACT

5198200619

Bastien Moineau, PhD

Role: CONTACT

4166054570

Facility Contacts

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James Tung, PhD

Role: primary

5198200619

Other Identifiers

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Myant/Waterloo/42689

Identifier Type: -

Identifier Source: org_study_id

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