Recruiting

Observational Study

Sponsor:

Myant Medical Corp.

Code:

NCT05898555

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

Skiin garment and pods

Study Details

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.

Conditions

Healthy

Study ID

NCT05898555

Start date

May 26, 2023

Status verified date

Mar, 2024

Completion date

Jun 30, 2024

Anticipated

Primary completion date

May 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy individuals

Gait study protocol

Interventions

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.

Primary outcome measure

  • Error in step length metric [ Time Frame: Collection during the single study session of 1.5 hours. ]
  • Error in stride length metric [ Time Frame: Collection during the single study session of 1.5 hours. ]
  • Error in cadence metric [ Time Frame: Collection during the single study session of 1.5 hours. ]
  • Error in step duration (s) metric, and its asymmetry [ Time Frame: Collection during the single study session of 1.5 hours. ]
  • Error in stride duration (s) metric, and its asymmetry [ Time Frame: Collection during the single study session of 1.5 hours. ]
  • Error in stance duration (s) metric, and its asymmetry [ Time Frame: Collection during the single study session of 1.5 hours. ]
  • Error in swing duration (s) metric, and its asymmetry [ Time Frame: Collection during the single study session of 1.5 hours. ]
  • Error in initial double support (s) metric, and its asymmetry [ Time Frame: Collection during the single study session of 1.5 hours. ]
  • Error in terminal double support (s) metric, and its asymmetry [ Time Frame: Collection during the single study session of 1.5 hours. ]
  • Error in double support (s) metric, and its asymmetry [ Time Frame: Collection during the single study session of 1.5 hours. ]
  • Error in single limb support (s) metric, and its asymmetry [ Time Frame: Collection during the single study session of 1.5 hours. ]
  • Error in gait speed metric [ Time Frame: Collection during the single study session of 1.5 hours. ]
  • Error in stride speed metric [ Time Frame: Collection during the single study session of 1.5 hours. ]
  • Error in mean CoM sway distance [ Time Frame: Collection during the single study session of 1.5 hours. ]
  • Error in mean CoM sway velocity [ Time Frame: Collection during the single study session of 1.5 hours. ]
  • Error in CoM sway area [ Time Frame: Collection during the single study session of 1.5 hours. ]
  • Error in CoM sway frequency [ Time Frame: Collection during the single study session of 1.5 hours. ]

Central Contacts and Locations

Central contacts

James Tung, PhD

5198200619james.tung@uwaterloo.ca

Bastien Moineau, PhD

4166054570bastien.moineau@myant.ca

Locations

University of Waterloo - Engineering 7

Recruiting

Waterloo, Ontario, Canada, N2L3G1

Contacts

James Tung, PhD

5198200619james.tung@uwaterloo.ca

More Information

Sponsor

Myant Medical Corp.

Last update posted

Mar 12, 2024

Last verified

Mar, 2024

Keywords

  • Gait analysis
  • Wearable electronic devices

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Myant Medical Corp. on 2024-03-12.