Clinical trial NCT06679608: Prospective Longitudinal Multicentric Study to Evaluate Syde® Digital Endpoints in Healthy Adults
Official title: Prospective Longitudinal Multicentric Study to Evaluate Syde® Digital Endpoints in Healthy Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Adults
Lead sponsor: SYSNAV
Sponsor class: INDUSTRY
First posted: 2024-11-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be initially provided with information on the study through Ethics Committee validated advertising supports (paper and electronic posters and flyers). These supports will be displayed and distributed by the investigational sites.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Longitudinal change of SV95C (stride velocity 95th centile)
timeFrame: 2 years
Secondary outcomes:
measure: Assess the transversal adherence of the Syde® device in healthy adults
timeFrame: Baseline
measure: Assess the transversal acceptability of the Syde® device in healthy adults
timeFrame: Baseline
measure: Assess the longitudinal adherence of the Syde® device in healthy adults
timeFrame: 2 years
measure: Assess the longitudinal acceptability of the Syde® device in healthy adults
timeFrame: 2 years
measure: Assess the reliability of Syde® in healthy adults
timeFrame: 2 years
measure: Evaluate in this healthy adult cohort the transversal effect on Syde® digital endpoints of gender
timeFrame: Baseline
measure: Evaluate in this healthy adult cohorts the transversal effect on Syde® digital endpoints of age
timeFrame: Baseline
measure: Evaluate in this healthy adult cohorts the transversal effect on Syde® digital endpoints of BMI
timeFrame: Baseline
measure: Investigate the relationship between changes in Syde® derived endpoints and changes in age
timeFrame: Month 6, Month 12, Month 18, Month 24
measure: Investigate the relationship between changes in Syde® derived endpoints and changes in BMI
timeFrame: Month 6, Month 12, Month 18, Month 24
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant (HFME)
city: Pontoise
country: France
facility: Hôpital NOVO (Nord-Ouest Val d'Oise)
city: Rouen
country: France
facility: CHU ROUEN - Hôpital Charles Nicolle
city: Vernon
country: France
facility: SYSNAV
Study officials:
References: