- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05898555
Validering av smarte plagg for gangklassifisering
Validering av smarte plagg for gang- og balansevurdering
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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Ontario
-
Waterloo, Ontario, Canada, N2L3G1
- University of Waterloo - Engineering 7
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
A convenience-sample of 20 healthy individuals will be recruited for this study.
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Error in step length metric
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: James Tung, PhD, University of Waterloo
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Myant/Waterloo/42689
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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