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临床试验/NCT01565044
NCT01565044已完成不适用

Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2012年9月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Fugl Meyer assessment (upper extremity) of motor recovery following stroke

研究概览

简要总结

Many patients retain upper-limb motor impairment following stroke. Most conventional rehabilitation techniques are aimed to improve motor intentional movement by repeated exercises. These techniques require attentional load and are responsible for significant fatigue that probably represents a limiting factor. Alternatively, the automatic control of action is now well documented. A rehabilitation method based on this principle could allow recovery of more natural movements.

Hypothesis: Stimulating automatic motricity improves upper-limb motor skills compared with a rehabilitation technique based on intentional movements.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All subjects must be between the ages of 18-80 and must not be pregnant
  • Patients volunteer to participate in the study, with a written informed consent signed
  • Affiliation to a national health insurance program
  • Hemiplegia after stroke
  • Stroke onset >6 weeks and <4 years prior to study enrollment
  • Patients able to perform the exercises on the automated table

排除标准

  • Pregnancy
  • Excessive pain in any joint of the paretic extremity (VAS>5)
  • Coexistent major neurological or psychiatric disease as to decrease number of confounders
  • Subjects with global aphasia and deficits of comprehension
  • Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing

研究组 & 干预措施

" AUTO " Group

Experimental

干预措施: motor training (Other)

" CONTROL " Group

Sham Comparator

干预措施: motor training (Other)

结局指标

主要结局

Fugl Meyer assessment (upper extremity) of motor recovery following stroke

时间窗: 2 weeks following the last day of the intervention (Day 26)

we are looking for a change in scores between the baseline session score (Day 1), and those collected during this follow-up session (Day 26).

次要结局

  • Fugl Meyer assessment (upper extremity) of motor recovery following stroke(immediately following the last day of the intervention (Day 12))
  • modified Ashworth scale(immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26))
  • Visual Analog Pain Scale(immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26))
  • Box and block test(immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26))
  • Frenchey Arm Test(immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26))
  • Motor Activity Log (MAL(immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26))
  • Functional independence scale (MIF)(immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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