- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05898555
Validation des vêtements intelligents pour la classification de la marche
Validation des vêtements intelligents pour l'évaluation de la marche et de l'équilibre
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Ontario
-
Waterloo, Ontario, Canada, N2L3G1
- University of Waterloo - Engineering 7
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
A convenience-sample of 20 healthy individuals will be recruited for this study.
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Healthy individuals
Gait study protocol |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Error in step length metric
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
|
Error in stride length metric
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
|
Error in cadence metric
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
|
Error in step duration (s) metric, and its asymmetry
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
|
Error in stride duration (s) metric, and its asymmetry
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
|
Error in stance duration (s) metric, and its asymmetry
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
|
Error in swing duration (s) metric, and its asymmetry
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
|
Error in initial double support (s) metric, and its asymmetry
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
|
Error in terminal double support (s) metric, and its asymmetry
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
|
Error in double support (s) metric, and its asymmetry
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
|
Error in single limb support (s) metric, and its asymmetry
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
|
Error in gait speed metric
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
|
Error in stride speed metric
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
|
Error in mean CoM sway distance
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
|
Error in mean CoM sway velocity
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
|
Error in CoM sway area
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
|
Error in CoM sway frequency
Délai: 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. |
Collection during the single study session of 1.5 hours.
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: James Tung, PhD, University of Waterloo
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Myant/Waterloo/42689
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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