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

Recruiting

• Conditions: Healthy Adults

• Registration Number: NCT06679608
• Lead Sponsor: SYSNAV

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-11-06
• Study First Posted: 2024-11-07
• Status Verified: 2025-01
• Study Start: 2025-01-20
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27
• Primary Completion: 2028-01-20
• Study Completion: 2028-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Longitudinal change of SV95C (stride velocity 95th centile)	2 years	Change of SV95C between baseline and Month 6, Month 12, Month 18 and Month 24.

Secondary Outcome Measures

Name	Time	Method
Assess the transversal adherence of the Syde® device in healthy adults	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
Assess the transversal acceptability of the Syde® device in healthy adults	Baseline	Usability score at baseline
Assess the longitudinal adherence of the Syde® device in healthy adults	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
Assess the longitudinal acceptability of the Syde® device in healthy adults	2 years	Change in usability score between baseline and Month 24
Assess the reliability of Syde® in healthy adults	2 years	Reproducibility assessed by ICC (Intra-Class Correlation) and Bland and Altman analysis at each timepoint
Evaluate in this healthy adult cohort the transversal effect on Syde® digital endpoints of gender	Baseline	Correlation between Syde® derived endpoints and gender. The Syde® derived endpoints will include the SV95C (stride velocity 95th centile).
Evaluate in this healthy adult cohorts the transversal effect on Syde® digital endpoints of age	Baseline	Correlation between Syde® derived endpoints and age. The Syde® derived endpoints will include the SV95C (stride velocity 95th centile) .
Evaluate in this healthy adult cohorts the transversal effect on Syde® digital endpoints of BMI	Baseline	Correlation between Syde® derived endpoints and BMI. The Syde® derived endpoints will include the SV95C (stride velocity 95th centile) .
Investigate the relationship between changes in Syde® derived endpoints and changes in age	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.
Investigate the relationship between changes in Syde® derived endpoints and changes in BMI	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.

Trial Locations

Locations (4)

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

Hôpital NOVO (Nord-Ouest Val d'Oise); 🇫🇷 Pontoise, France

SYSNAV; 🇫🇷 Vernon, France

CHU ROUEN - Hôpital Charles Nicolle; 🇫🇷 Rouen, France