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临床试验/NCT03418519
NCT03418519Unknown不适用

A Comparative Analysis on Physical Activity Performance and Motor Function of Affected Upper Extremity Before and After a CIMT Program in Young Children With Hemiparetic Cerebral Palsy

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年1月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Accelerometers(physical activity performance)

研究概览

简要总结

This study evaluates CIMT(Constraint Induced Movement Therapy) in the treatment of physical activity performance and motor function of the weaker extremity in young children with cerebral palsy. Half of participants will receive CIMT while the other half will receive no treatment.

详细描述

Constraint-induced movement therapy (CIMT) is a short-term, intensive treatment to promote functional arm and hand skills in people with hemiparesis. It usually involves constraint of the non-involved extremity and intensive movement practice of the weaker extremity.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Months 至 36 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •diagnosed with spastic hemiplegic cerebral palsy
  • •age between 18 months and 36 months
  • •Mini-MACS level 1-4

排除标准

  • •botox injection in upper extremity within 6 months
  • •poor cooperation with cognitive impairment
  • •any musculoskeletal disease
  • •visual or hearing impairment
  • •uncontrollable epilepsy
  • •skin damage that makes impossible for participant to wear a splint
  • •Mini-MACS level 5

研究组 & 干预措施

CIMT group

Experimental

Two-hour mCIMT per day for 15 days (dosage = 30 hours)

24-hour restraint for 3 weeks

干预措施: Constraint Induced Movement Therapy (Other)

Control group

No Intervention

no CIMT

结局指标

主要结局

Accelerometers(physical activity performance)

时间窗: 3 days

For the upper limb use assessment, participants wear two accelerometers (one on each wrist). To quantify the affected upper limb movement relative to the unaffected upper limb before and after the CIMT program, two other variables are computed: use ratio and magnitude ratio. The use ratio is the ratio of the active duration for the affected arm to that for the unaffected arm. The magnitude ratio quantifies the contribution of the affected upper limb to activity.

Pediatric Motor Activity Log(PMAL)

时间窗: 30 minutes

The Pediatric Motor Activity Log (PMAL) is a parent-report measure of the use, by children with hemiplegic cerebral palsy, of their affected upper limb in everyday activities. Each item is scored 0-5(0= Never used affected arm , 5= Used affected arm on almost every occasion)

次要结局

  • Peabody Developmental Motor Scales-2(PDMS-2)(30 minutes)
  • Pediatric Evaluation of Disability Inventory(PEDI)(30 minutes)
  • Gross motor function measure - 66(GMFM-66)(30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeong Yi Kwon

Professor

Samsung Medical Center

研究点 (1)

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