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临床试验/NCT02464085
NCT02464085Unknown不适用

Characterising Arm Recovery in People With Severe Stroke

University of British Columbia1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
3T Magnetic Resonance Imaging (MRI)

研究概览

简要总结

The main goal of this program of research is to advance our understanding of how the severely damaged brain changes over the first 12-months post stroke. The investigators will determine 'who recovers', 'who does not recover', and 'why'

详细描述

The main goal of this program of research is to advance our understanding of how the severely damaged brain changes over the first 12-months post stroke. The prevalence and severity of stroke related arm disability is increasing and the prospect of optimal recovery is poor. Studies have demonstrated that stroke survivors with severe disability lack early indicators (<7-days to <1-month post-stroke) of a good prognosis, such as active movement at the shoulder and wrist and integrity of the corticospinal tract. This has propagated the clinical belief that this cohort are unlikely to functionally benefit from rehabilitation efforts. However, it is possible that indicators of potential for recovery - either neuroanatomical or clinical - may present in individuals with severe stroke later, that is beyond the early time-period. Indeed, there is increasing evidence of the potential for ongoing improvements in motor performance in response to intensive interventions that are undertaken 6-months or more post-stroke. This therefore, implies that there is some degree of untapped recovery potential. However, as very few studies have longitudinally explored the potential indicators of recovery in a severe cohort, the dynamic capacity of the severely damaged remains unknown. Thus, there is a need to determine 'who recovers', 'who does not recover', and 'why' to be able to promote optimal arm recovery in people with severe impairment after stroke. We will assess stroke survivors <4-weeks, 3-months, 6-months and 12-months post stroke using a range of neuroimaging and clinical outcome measures. The findings from this study will build the foundations for more personalized health care options for people with severe arm impairment post stroke.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults aged 18 to 90 years;
  • sustained their first stroke;
  • demonstrate subacute (<1 month) and severe upper limb motor deficits (defined by a SAFE [shoulder abduction and finger extension] score of <5 out of 10 points); and
  • can follow single stage commands

排除标准

  • neurological condition other than stroke e.g., Parkinson's disease

结局指标

主要结局

3T Magnetic Resonance Imaging (MRI)

时间窗: up to 12-months

Determine the structural and functional connectivity of the brain using diffusion weighted imaging, resting state-functional magnetic resonance imaging and myelin water fraction imaging.

次要结局

  • Shoulder abduction and finger extension (SAFE)(12-months)
  • Fugl-Meyer Assessment (arm and sensory)(<4wks, 3-months, 6-months, 12-months)
  • PASS (Postural Assessment Scale for Stroke patients)(<4wks, 3-months, 6-months, 12-months)
  • 10-metre walk test(<4wks, 3-months, 6-months, 12-months)
  • Montreal Cognitive Assessment (MoCA)(<4wks, 3-months, 6-months, 12-months)
  • Motor Assessment Scale items 6,7,8(<4wks, 3-months, 6-months, 12-months)
  • REACH (Rating of Everyday Arm Use in the Community and Home)(<4wks, 3-months, 6-months, 12-months)
  • Accelerometry(<4wks, 3-months, 6-months, 12-months)
  • Dose of upper limb training(<4wks, 3-months, 6-months, 12-months)
  • National Institute of Stroke Severity Scale(<4-weeks)
  • Oxfordshire Bamford Classification(<4-weeks)
  • Myelin water fraction imaging (WMI)(<4wks, 3-months, 6-months, 12-months)
  • Meaningful arm recovery questionnaire(<4wks, 3-months, 6-months, 12-months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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