HealthyNCT05898555
Validation of Smart Garments for Gait Classification
An observational study of Healthy, run by Myant Medical Corp. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Skiin garment and pods
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 26 May 2023to 14 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A convenience-sample of 20 healthy individuals will be recruited for this study.
Who may be able to join
- Healthy male and female adults aged 18y - 64y old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Specific objectives of this study are:
- 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);
- 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
- Healthy
- Being tested
- Skiin garment and pods
- Keywords
- Gait analysis, Wearable electronic devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skiin garment and podsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Gait study protocol Receives: Device: Skiin garment and pods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Error in step length metric
The difference between step lengths calculated from Skiin data and from Vicon data for each scripted gait tasks.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Collection during the single study session of 1.5 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start26 May 2023
- Primary completion18 Sep 2023
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myant Medical Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Responsible party
- Sponsor
- Investigators
- James Tung, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898555
- Sponsor's protocol ID
- Myant/Waterloo/42689
- Status last verified
- Mar 2024
- First submitted
- 1 Jun 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Smart Garments for Gait and Balance Assessment
- ClinicalTrials.gov ID
- NCT05898555
- Acronym / sponsor ID
- Myant/Waterloo/42689
- Conditions
- Healthy
- Keywords
- Gait analysis, Wearable electronic devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Myant Medical Corp.Industry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Study start
- 26 May 2023 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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);
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | Device: Skiin garment and podsGait study protocol |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A convenience-sample of 20 healthy individuals will be recruited for this study.
Key inclusion criteria (1 listed)
- Healthy male and female adults aged 18y - 64y old
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skiin garment and podsParticipants 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. | Device | Healthy individuals |
Primary outcome
Error in step length metric
Time frame: 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 stride length metric
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 stance duration (s) metric, and its asymmetry
Time frame: 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 swing duration (s) metric, and its asymmetry
Time frame: 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 initial double support (s) metric, and its asymmetry
Time frame: 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 terminal double support (s) metric, and its asymmetry
Time frame: 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 double support (s) metric, and its asymmetry
Time frame: 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 single limb support (s) metric, and its asymmetry
Time frame: 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 gait speed metric
Time frame: 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.
Error in stride speed metric
Time frame: 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 mean CoM sway distance
Time frame: 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 mean CoM sway velocity
Time frame: 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 CoM sway area
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Tung, PhD principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Myant Medical Corp. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Error in step length metric (time frame: Collection during the single study session of 1.5 hours.). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.