NCT07388992招募中不适用
Investigating Specific Gait Patterns in Individuals Living With Multiple Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- SYSNAV
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- description of ambulation pattern in controlled environment in people living with multiple sclerosis (pwMS) with different disease severities
研究概览
简要总结
The study aims to investigate specific ambulation patterns characteristic of the quality of gait in people with MS (pwMS)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- 是
入选标准
- •For people living with multiple sclerosis (pwMS):
- •Age at inclusion between =18 and =65 years old
- •Signed informed consent and ability to comply with study and follow-up.
- •Confirmed MS diagnosis according to McDonald criteria (2017)
- •Expanded Disability Status Scale EDSS = 6
- •Stable treatment for 2 months before inclusion (for both disease modifying and symptomatic therapies)
- •Ability and willingness to participate in and comply with all study procedures defined in the protocol
- •Subject will be eligible for enrollment in this study only if either affiliated to, or a beneficiary of a social security category
- •For Healthy volunteers :
- •Age at inclusion between =18 and =65 years old
- •Signed informed consent and ability to comply with study and follow-up.
- •Ability and willingness to participate in and comply with all study procedures defined in the protocol
- •Subject will be eligible for enrollment in this study only if either affiliated to, or a beneficiary of a social security category
排除标准
- •Participants with a relapse within the past 3 months before the inclusion
- •Participants with significant cognitive disorders, limiting the understanding of the exercises to be performed or presence of apparent communication difficulties hindering the correct collection of data, as assessed by the investigator
- •Past or present pathology other than MS or surgery or trauma impacting gait, ambulatory function or upper limb function, as assessed by the investigator
- •Vulnerable adults: individuals subject to a legal protection measure (guardianship, limited guardianship, or judicial protection) or unable to express their consent.
- •For healthy volunteers (HV):
- •Participants with significant cognitive disorders, limiting the understanding of the exercises to be performed or presence of apparent communication difficulties hindering the correct collection of data, as assessed by the investigator
- •Past or present pathology or surgery or trauma impacting gait, ambulatory function or upper limb function, as assessed by the investigator
- •Vulnerable adults: individuals subject to a legal protection measure (guardianship, limited guardianship, or judicial protection) or unable to express their consent.
研究组 & 干预措施
Healthy Adult
people living with Multiple Sclerosis
结局指标
主要结局
description of ambulation pattern in controlled environment in people living with multiple sclerosis (pwMS) with different disease severities
时间窗: enrollment
Measurement of daily life-like activity movements by Optical Motion Capture, pressure sensitive walkway and wearable sensors
次要结局
未报告次要终点
研究者
研究点 (1)
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