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

NCT06679608 | Active Not Recruiting

• 2 other identifiers: PR5030-722024-A01925-42
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 4

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.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

• Longitudinal change of SV95C (stride velocity 95th centile)

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

  2 years

Secondary Outcomes (10)

• Assess the transversal adherence of the Syde® device in healthy adults

  Baseline

• Assess the transversal acceptability of the Syde® device in healthy adults

  Baseline

• Assess the longitudinal adherence of the Syde® device in healthy adults

  2 years

• Assess the longitudinal acceptability of the Syde® device in healthy adults

  2 years

• Assess the reliability of Syde® in healthy adults

  2 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SYSNAV: lead

Study Sites (4)

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

Bron, 69500, France

Location

Hôpital NOVO (Nord-Ouest Val d'Oise)

Pontoise, 95300, France

Location

CHU ROUEN - Hôpital Charles Nicolle

Rouen, 76000, France

Location

SYSNAV

Vernon, 27200, France

Location

Study Officials

• Shotaro Tachibana

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: November 7, 2024
• Study Start: January 20, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

FR (4)