- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT05898555
Walidacja inteligentnej odzieży do klasyfikacji chodu
Walidacja inteligentnej odzieży do oceny chodu i równowagi
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.
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Ontario
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Waterloo, Ontario, Kanada, N2L3G1
- University of Waterloo - Engineering 7
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
A convenience-sample of 20 healthy individuals will be recruited for this study.
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Error in step length metric
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: James Tung, PhD, University of Waterloo
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- Myant/Waterloo/42689
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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