NCT06346704终止不适用
Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis (NHS-MS-EGYPT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- SYSNAV
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Longitudinal change of 95th centile of stride velocity
研究概览
简要总结
The study aims to assess the validity of real-world activity monitoring by the Syde® wearable device in subjects with multiple slclerosis. The Syde® collected data will be compared to on-site conventional clinical endpoints for MS pathology (EDSS, FSS and T25FWT). Subjects with multiple sclerosis 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 subject aged from 18 to 65 years old.
- •Signed informed consent and ability to comply with study and follow-up.
- •Diagnosed with MS base on 2017 McDonald criterion
- •No clinical or radiological relapse within the last 3 months
- •For patient under treatment, the molecule and its dose should be stable about 2 months before inclusion
- •Subject willing and able to comply to all study procedures including the Syde® related ones
排除标准
- •Patient with a cognitive or communicational disorder disturbing the understanding of the tasks or data collection
- •Previous or current disorder with an impact on current ambulation or motor function
- •Patient who have had surgery or traumatic injury in upper or lower limb within the last 6 months before the inclusion or patients who have had major surgery or trauma within the last 6 months before the inclusion
结局指标
主要结局
Longitudinal change of 95th centile of stride velocity
时间窗: 2 years
change between baseline and Month 6, Month 12, Month 18 and Month 24
次要结局
- Correlation of the Syde® variables with the clinical assessments EDSS, FSS and T25FWT(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Electronic Monitoring of Disease Activity in Patients With Chronic Inflammatory Demyelinating PolyneuropathyCIDPNCT05723848Heinrich-Heine University, Duesseldorf46
进行中（未招募）
不适用
Prospective Longitudinal Multicentric Study to Evaluate Syde® Digital Endpoints in Healthy AdultsHealthy AdultsNCT06679608SYSNAV129
已完成
不适用
Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential TechnologyEpilepsyNCT04284072Universitaire Ziekenhuizen KU Leuven496
尚未招募
不适用
A Multimodal Wearable Device-based Study to Evaluate the Efficacy of an Exercise Prescription Intervention in IBDInflammatory Bowel DiseasesNCT06427135Ping An56
招募中
不适用
Wearable Technology as an Objective Tool for Measuring Running GaitWalkingRunningGaitGait AnalysisNCT05277181Northumbria University80