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

SYSNAV7 个研究点分布在 1 个国家目标入组 129 人2025年1月20日

适应症Healthy Adults

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Healthy Adults
发起方: SYSNAV
入组人数: 129
试验地点: 7
主要终点: Longitudinal change of SV95C (stride velocity 95th centile)
状态: 进行中（未招募）
最后更新: 3个月前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2025年1月20日

结束日期

2027年12月1日

最后更新

3个月前

研究类型

Observational

性别

All

研究者

发起方

SYSNAV

责任方

Sponsor

入排标准

入选标准

•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

排除标准

•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

结局指标

主要结局

Longitudinal change of SV95C (stride velocity 95th centile)

时间窗: 2 years

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

次要结局

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)
Evaluate in this healthy adult cohort the transversal effect on Syde® digital endpoints of gender(Baseline)
Evaluate in this healthy adult cohorts the transversal effect on Syde® digital endpoints of age(Baseline)
Evaluate in this healthy adult cohorts the transversal effect on Syde® digital endpoints of BMI(Baseline)
Investigate the relationship between changes in Syde® derived endpoints and changes in age(Month 6, Month 12, Month 18, Month 24)
Investigate the relationship between changes in Syde® derived endpoints and changes in BMI(Month 6, Month 12, Month 18, Month 24)