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临床试验/NCT01643109
NCT01643109已完成不适用

Childhood Hemiplegic CP Integrated Neuroscience Discovery Network (CP-NET) Theme IIIa: Constraint Induced Movement Therapy (CIMT)- Neuroimaging Predictors of Positive Response to Constraint

Holland Bloorview Kids Rehabilitation Hospital6 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
6
主要终点
Change from baseline in Assisted Hand Assessment

研究概览

简要总结

CIMT has shown great promise in helping children and adults regain lost function in a disabled limb by forcing its use through an intensive motor training program and constraining the unaffected arm with a cast. However, relatively little is known about the underlying mechanisms of CIMT in hemiplegic CP. This project will use an integrated translation model to explore neuroimaging predictors of a positive clinical response to CIMT.

详细描述

The primary research objective is to evaluate neuroimaging predictors of a positive response to CIMT in children with hemiplegic CP secondary to a middle cerebral artery territory stroke (MCA). A focus on the MCA territory is chosen as (1) it targets children with significant hand impairment who have the potential to benefit from CIMT, (2) is the most common neuropathological subtype, and (3) allows for enhanced homogeneity for the matching of case and comparison groups. The primary research question is: In children aged 7 to 16 years with hemiplegic CP secondary to an MCA stroke, are there neuroimaging predictors of a positive response to CIMT, a positive response being defined by an improvement in the Assisting Hands Assessment (AHA) one month after CIMT?

Neuroimaging predictor variables include laterality index (LI) of the primary M1 and S1 areas on fMRI, IHI evaluated by resting state fMRI, dissociation of the M1 and S1 for the hemiplegic hand measured by fMRI, size and vascular distribution of the MCA lesion with T2 weighted MRI, and white matter tract abnormality with Diffusion Tensor Imaging (DTI). We hypothesize that a negative LI, a non-dissociated M1 and S1, low IHI, small size of infarction, and large size of the contralateral corticospinal tract will predict a positive response to constraint. An evaluation of the neuroimaging predictor variables on the persistence of a positive response to CIMT at 6 months as measured by the AHA will also be explored. A secondary objective will evaluate change in the neuroimaging variables from baseline to one month post CIMT by comparing children in the case group who have received CIMT and a comparison group who are matched on baseline QUEST scores.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Hemiplegic CP secondary to an MCA infarct
  • Age between 7 and 16 years
  • Ability to co-operate, understand, and follow simple instructions for neuro-imaging outcome measurement: The functional MRI protocol will require some cooperation and the child will need to lie still in a confined place for approximately 45-60 min.
  • No previous CIMT within 12-months of study entry or Botulinum toxin upper limb injections within 6-months of study entry.

排除标准

  • 未提供

结局指标

主要结局

Change from baseline in Assisted Hand Assessment

时间窗: baseline, 1-month after intervention and 6-months

The primary outcome measure for this study will be the assisted hand assessment (AHA). This test is the gold standard in paediatric constraint research to assess the use of the assisting hand in bilateral activities (hand use) in children with hemiplegic CP with established reliability, validity and responsiveness. Importantly it has undergone the rigour of a Rasch analysis in its development.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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