Actimeric Monitoring of the Use of the Paretic Upper Limb in the Activities of Daily Living of the Post-chronic Stroke Subject in a Home Environment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- FuncUseRatio
研究概览
简要总结
After a stroke, 80% of patients continue to have difficulty using their paretic upper limb in activities of daily living (ADL) despite post-stroke rehabilitation practices that aim to promote the use of the paretic upper limb. It is known that functional recovery depends on actual use (Use it or Loose it), but one-time measurements in the clinic do not allow quantification of the actual use of the paretic upper limb in daily life (in the person's living environment).
The investigators hypothesize the feasibility of quantifying functional use of the paretic upper limb by actimetry in clinical routine.
详细描述
After a stroke, 80% of patients continue to have difficulty using their paretic upper limb in activities of daily living (ADL) despite post-stroke rehabilitation practices that aim to promote the use of the paretic upper limb. It is known that functional recovery depends on actual use (Use it or Loose it), but one-time measurements in the clinic do not allow quantification of the actual use of the paretic upper limb in daily life (in the person's living environment).
Project will monitor 30 chronic and 30 healthy subjects over one week period using two wrist worn sensors .
The main objective is to objectively quantify by actimetry, over 7 days, the real functional use of the paretic upper limb in the activities of daily living of post-stroke hemiparetic subjects in chronic phase, by the functional use ratio between the two arms (UseRatio).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria common to all participants:
- •Be between 18 and 90 years old
- •Post-stroke subjects should:
- •Having a stroke with motor sequelae in the upper limb
- •Be in the chronic phase (>3 months post-stroke) of a stroke whatever the aetiology
排除标准
- •Non inclusion criteria common to all participants:
- •Absence of free, informed and express oral consent
- •No affiliation to a French social security system or beneficiary of such a system
- •Patient protected by law
- •Pregnant or breastfeeding women
- •Not eligible for inclusion, post-stroke subjects:
- •Not understanding the constraints of the study
- •Have cognitive impairments that prevent them from understanding the study
- •With a known hemigligence in the medical record (omission > 8 on bells test)
结局指标
主要结局
FuncUseRatio
时间窗: 7 days
The paretic functional use score is a ratio of functional movements performed by the paretic upper limb to the sum of functional movements performed by the paretic and non-paretic upper limbs (in percentage %).
次要结局
- Use(7 days)
- Intensity(7 days)
- Motor deficit(During the inclusion visit or information taken in the medical file)
- Dispersion of UseRatio(6 months)
- Profil(During intervention)