NCT06679608进行中（未招募）不适用
Prospective Longitudinal Multicentric Study to Evaluate Syde® Digital Endpoints in Healthy Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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)
研究概览
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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)
研究者
研究点 (7)
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