NCT05898555

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

11 months

First QC Date

June 1, 2023

Last Update Submit

March 11, 2024

Conditions

Healthy

Keywords

Gait analysisWearable electronic devices

Outcome Measures

Primary Outcomes (17)

  • 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.

Study Arms (1)

Healthy individuals

Gait study protocol

Device: Skiin garment and pods

Interventions

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.

Healthy individuals

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- Healthy male and female adults aged 18y - 64y old

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Waterloo - Engineering 7

Waterloo, Ontario, N2L3G1, Canada

RECRUITING

Study Officials

  • James Tung, PhD

    University of Waterloo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James Tung, PhD

CONTACT

5198200619james.tung@uwaterloo.ca

Bastien Moineau, PhD

CONTACT

4166054570bastien.moineau@myant.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 12, 2023

Study Start

May 26, 2023

Primary Completion

May 1, 2024

Study Completion

June 30, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations

CA(1)