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Trial · NCT07031518

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTotal Recording Time Over 2 Months2 monthsTotal number of hours recorded by the Syde® wearable device over a 2-month period.
PrimaryMedian Daily Recording Time2 monthsMedian number of hours recorded per day by the Syde® device over the 2-month period.
PrimaryDays to Reach 180 Recording Hours2 monthsNumber of days required to reach 180 hours of recording, considered the optimal threshold for analysis.
PrimaryIntra-Class Correlation of Syde® OutcomesEntire recording period over 2 monthsIntra-Class Correlation (ICC) of each Syde® outcome calculated over slices of x hours (x = 10 to 90) of data per patient to assess reliability.
SecondaryCorrelation Between Syde® Variables and WOMAC 3.1 ScoresBaseline and 2 monthsSpearman correlation between digital variables and WOMAC 3.1 scores at 2 months.
SecondaryCorrelation Between Syde® Variables and Timed TestsBaseline and 2 monthsCorrelation between digital variables and results from 40 m self-paced test, 30 s chair stand test, and timed up and go test.
SecondaryCorrelation Between Syde® Variables and Kellgren-Lawrence GradeBaselineSpearman correlation between digital variables and Kellgren-Lawrence grade.
SecondaryDiscriminative Power of Syde® VariablesEntire recording period over 2 monthsDifferences in Syde® outcomes between patients and controls, and among subgroups based on WOMAC 3.1 scores.
SecondaryQualitative Interview on Mobility and UsabilityBaseline and Month 2Qualitative data from interviews exploring mobility limitations, important measures, and impact on daily life.
SecondaryStiffness Index Based on ImmobilityEntire recording period over 2 monthsRatio of outcome measures after 0.5-3 hours of immobility (≥10 minutes) compared to full-day values excluding immobility periods.
SecondaryOptimal Time of Day for RecordingEntire recording period over 2 monthsMetric properties of outcomes calculated for various time windows (e.g., 1-11h, 2-12h) to assess morning stiffness and evening fatigue.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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