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临床试验/NCT01076257
NCT01076257已完成不适用

Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage: Evidence of Kinematic Study

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2009年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
2
主要终点
Kinematic analysis

研究概览

简要总结

This research centers on the comparison of the immediate efficacy (right after therapy) and the maintained efficacy (3 months and 6 months) between "Modified Constraint-Induced Movement Therapy" (mCIMT) group and control group at different age.

详细描述

"Modified Constraint-Induced Movement Therapy" is one of the most recent treatments for children with Brain damage.

This well-designed and follow-up RCT study compared home-based CIT with a control intervention (traditional rehabilitation, TR) by combining kinematic analysis and clinical evaluation, which is possible to examine whether functional improvement is accompanied by a change in motor control. We hypothesized that home-based CIT would induce better motor control strategies (shorter RT, MT, lesser MUs, MGA, and PMGA, and larger peak velocity (PV)) for greater functional gains than TR. Furthermore, the beneficial effects would be maintained at 3 and 6 months of follow-up. Findings of this study allow clinicians to understand the underlying motor control changes for functional improvement after home-based CIT.

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
4 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Development learned-nonuse
  • Age range 4y/o-15y/o
  • Wrist ext 10˚, MP j't ext 10˚ in affected U/E
  • Can fallow up the simple instruction
  • Modified Ashworth Scale ≦2
  • Pediatric Motor Activity Log ≦2.5 (average)

排除标准

  • Related muscle skeleton surgery
  • Selective dorsal rhizotomy
  • Botulinum toxin in 6 months
  • Visual perception impaired
  • Hearing perception impaired
  • Balance ability impaired (in constrained)

结局指标

主要结局

Kinematic analysis

时间窗: 4 weeks (post-treatment), 12 week, 24 week

Bruininks-Oseretsky Test of Motor Proficiency (BOTMP)

时间窗: 4 weeks (post-treatment), 12 week, 24 week

All children underwent a series of upper limb assessments, including kinematic analysis and functional measures (primary and secondary outcomes), before the start of the intervention (pretreatment). An occupational therapist blinded to group assignment was trained to administer these measures. All participants underwent these assessments at 4 weeks immediately after intervention (post-treatment), and at 12-week follow-up and 24-week follow-up.

Peabody Development Motor Scales, subtest fine motor (PDMS-Ⅱ)

时间窗: 4 weeks (post-treatment), 12 week, 24 week

次要结局

  • Pediatric Motor Activity Log ( PMAL )(4 weeks (post-treatment), 12 week, 24 week)
  • Pediatric Functional Independence Measure ( WeeFIM )(4 weeks (post-treatment), 12 week, 24 week)
  • Cerebral palsy quality of life (CPQoL)(4 weeks (post-treatment), 12 week, 24 week)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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