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临床试验/NCT04536506
NCT04536506已完成不适用

Comparison of the Effectiveness of Bobath Therapy and Vojta Technique in Babies With Down Syndrome Aged 0-24 Months: A Randomized Controlled Study

Pamukkale University2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2019年9月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Alberta Infant Motor Scale

研究概览

简要总结

Different physiotherapy approaches and education programs are applied to minimize motor and mental impairment in children with Down syndrome (DS). The present study was conducted with the aim of comparing the effectiveness of two different physiotherapy approaches in babies with Down syndrome in the early period.

A total of 23 babies with DS aged between 0-24 months were included in the study. Infants were randomly divided to two groups: Bobath therapy (BT) group included 12 infants (6 girls and 6 boys) and Vojta technique (VT) group included 11 infants (4 girls and 7 boys). The infants were applied a total of 12 sessions of physiotherapy (twice weekly during 6 weeks). Alberta Infant Motor Scale (AIMS) was used for comparison of motor development level before and after the therapy. Emotional status of the mothers was evaluated with Beck Depression Scale (BDS) and quality of life was evaluated with Nottigham Health Profile (NHP).

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
None

入排标准

年龄范围
0 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • being between 0 and 2 years
  • being diagnosed with DS

排除标准

  • having an additional neuro-motor disease

结局指标

主要结局

Alberta Infant Motor Scale

时间窗: 12 weeks

Alberta Infant Motor Scale is a tool which evaluates the infants from baby to independently walking children and measures delay in motor performance, enables families and clinicians to obtain data about motor performance of the infant, compares motor performance before and after therapy. The child is observed when performing spontaneous behaviors with a certain postural control. The scale measures weight transfer, posture and anti-gravity movements at supine, prone, sitting and standing positions with 58 items. The child receives 1 point for the movements he/she can perform and 0 point for the ones that he/she cannot perform. It is a reliable test with norm reference and suitable for clinical use due to taking short time.

次要结局

  • Beck Depression Scale(12 weeks)
  • Nottingham Health Profile(12 weeks)

研究者

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

AYŞE ÜNAL

Research assistant

Pamukkale University

研究点 (2)

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相似试验

Bobath and Vojta Therapy for DS | 临床试验