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Active, Not Recruiting

NCT Number: NCT06679608

Prospective Longitudinal Multicentric Study to Evaluate Syde® Digital Endpoints in Healthy Adults

The study aims to constitute a longitudinal Syde® digital health technology (DHT) dataset to serve as a healthy adult reference for Syde® digital variables development and validation. Subjects will be assessed every 6 months for 2 years.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Adults

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon - Hôpital Femme Mère Enfant (HFME), Bron, France

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female aged between 18 and 65 years old
  • Signed informed consent
  • Subjects with a reported BMI ≥ 17 and ≤ 35
  • Subject with unlimited internet connection at home and authorizing automatic data upload
  • Subject willing and able to comply with all study procedures including:
  • baseline data and questionnaires data entry on EDC (electronic data capture) throughout the study
  • Syde® related procedures
  • Subject confirming to be affiliated to, or beneficiary from, a social security category

Exclusion criteria

  • Elite athletes (at a national level)
  • Pregnant women
  • Presence of an orthopedic, neuromuscular, or neurological pathology affecting walking gait quality or requiring a walking aid
  • Subjects reporting to have an incapacity or invalidity or to be affected by a chronic disease which can affect their activity and/or their lower limb function
  • Subjects reporting to have undergone recent surgical procedures, trauma (within 6 months), or affected by a disease or condition affecting lower limb function within 3 weeks before their inclusion

Treatment and study plan

Primary outcomes

  1. Longitudinal change of SV95C (stride velocity 95th centile)

    Time frame: 2 years

    Change of SV95C between baseline and Month 6, Month 12, Month 18 and Month 24.

Secondary outcomes

  1. Assess the transversal adherence of the Syde® device in healthy adults

    Time frame: Baseline

    • Number of subjects reaching the defined threshold of recording hours during the protocol defined period at baseline
    • Number of days necessary to reach the defined threshold of recording hours at baseline during the protocol defined period at baseline

  2. Assess the transversal acceptability of the Syde® device in healthy adults

    Time frame: Baseline

    Usability score at baseline

  3. Assess the longitudinal adherence of the Syde® device in healthy adults

    Time frame: 2 years

    • Change in number of subjects reaching the defined threshold of recording hours during the protocol defined periods between baseline and Month 6, Month 12, Month 18, Month 24
    • Change in number of days necessary to reach the defined threshold of recording during the protocol defined periods between baseline and Month 6, Month12, Month 18, Month 24

  4. Assess the longitudinal acceptability of the Syde® device in healthy adults

    Time frame: 2 years

    Change in usability score between baseline and Month 24

  5. Assess the reliability of Syde® in healthy adults

    Time frame: 2 years

    Reproducibility assessed by ICC (Intra-Class Correlation) and Bland and Altman analysis at each timepoint

  6. Evaluate in this healthy adult cohort the transversal effect on Syde® digital endpoints of gender

    Time frame: Baseline

    Correlation between Syde® derived endpoints and gender. The Syde® derived endpoints will include the SV95C (stride velocity 95th centile).

  7. Evaluate in this healthy adult cohorts the transversal effect on Syde® digital endpoints of age

    Time frame: Baseline

    Correlation between Syde® derived endpoints and age. The Syde® derived endpoints will include the SV95C (stride velocity 95th centile) .

  8. Evaluate in this healthy adult cohorts the transversal effect on Syde® digital endpoints of BMI

    Time frame: Baseline

    Correlation between Syde® derived endpoints and BMI. The Syde® derived endpoints will include the SV95C (stride velocity 95th centile) .

  9. Investigate the relationship between changes in Syde® derived endpoints and changes in age

    Time frame: Month 6, Month 12, Month 18, Month 24

    Comparison between changes in Syde® derived endpoints and changes in age between baseline and Month 6, Month 12, Month 18 and Month 24.

  10. Investigate the relationship between changes in Syde® derived endpoints and changes in BMI

    Time frame: Month 6, Month 12, Month 18, Month 24

    Comparison between changes in Syde® derived endpoints and changes in BMI between baseline and Month 6, Month 12, Month 18 and Month 24.

Sponsors and collaborators

Lead sponsor

SYSNAV

Industry

Registry information

Acronym: Syde-CAR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 7, 2024
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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