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临床试验/NCT02979743
NCT02979743Unknown不适用

MRI-based Neuroimaging Predictors of Clinical Improvements Following Occupational Therapy (OT) or OT Puls Acupuncture and Massage Methods in Children With Cerebral Palsy

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Fine motor function measure (scores)

研究概览

简要总结

The aim of this study is to explore the relationship between brain MRI-metrics and hand function observed in children with cerebral palsy (CP),compared between baseline and the third month, and thus determine the early MRI-based neuroimaging predictor of clinical improvement following therapy in children with CP.

详细描述

Cerebral palsy (CP) is the commonest cause of neurological disability in children. The upper limbs are often affected, with significant hand involvement from an early age.There are various methods of treatment for CP children with hand function disability. However, there is a lack of effective methods to predict the prognosis.

This prospective cohort study will include children with occupational therapy (OT) or OT plus acupuncture and massage methods. Children with CP will be evaluated in terms of upper limb motor function using the manual ability classification system (MACS), fine motor function measure (FMFM). The Brain injuries of Children will be evaluated by MRI.

The aim of this study is to explore the relationship between brain MRI-metrics and hand function, compared between baseline and the third month, and thus determine the early MRI-based neuroimaging predictors of clinical improvements following therapy in children with CP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • Age: 3-18 years
  • Spastic cerebral palsy
  • The complete clinical and MRI data

排除标准

  • previous acupuncture and massage methods
  • botulinum toxin upper limb injections
  • braces artifact, excessive motion, afraid to enter the MRI
  • parents were not interested in the MRI sessions

研究组 & 干预措施

Occupational therapy group

Placebo Comparator

The children worked with an occupational therapist for 4 hours a day for 5 days per week (totaling 40 hours) and initially concentrated on unilateral activities with the hemiplegic hand,and added bilateral activities during the second week.

干预措施: Occupational therapy (Behavioral)

Occupational therapy puls acupuncture and massage methods

Active Comparator

The patients receive occupational therapy puls acupuncture and massage methods.

干预措施: Occupational therapy (Behavioral)

Occupational therapy puls acupuncture and massage methods

Active Comparator

The patients receive occupational therapy puls acupuncture and massage methods.

干预措施: Occupational therapy puls acupuncture and massage methods (Other)

结局指标

主要结局

Fine motor function measure (scores)

时间窗: The 3rd month

It is acquired at 3 months later following therapy.

次要结局

  • Gross motor function measure and classification system (scores)(The 3rd month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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