跳至主要内容
临床试验/NCT00825175
NCT00825175已完成不适用

The Effect of Treadmill Training and Orthotic Use on the Development of Walking and Upright Play in Infants With Down Syndrome

University of Michigan2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2006年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Pattern of Gross Motor Development

研究概览

简要总结

This study determines the effect of orthotic use in combination with treadmill training on the development of gross motor skills and walking onset in infants with Down syndrome.

详细描述

The goal of this study is to determine if orthotic use impacts the development of walking and upright play skills over and above the impact that treadmill training alone has. Infants with Down syndrome who can pull to stand but not walk will be recruited and assigned to a group that receives treadmill training and orthoses or just treadmill training. The infants are followed monthly until they have one month of walking experience. During the monthly visits, the infants' gross motor development is tested and their upright play behavior is observed. At the end of the study each infants gait is evaluated. We believe that the orthoses will lead to a decreased age at walking onset, an improvement in gait patterns, and an improvement in upright play ability.

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
6 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Trisomy 21
  • Able to pull to stand but not walk

排除标准

  • Additional developmental diagnoses
  • Uncorrected vision or hearing impairments
  • Previous orthotic intervention
  • Previous treadmill intervention

研究组 & 干预措施

1

Active Comparator

Treadmill Training in infants with Down syndrome only

干预措施: Treadmill Training (Behavioral)

2

Experimental

Treadmill Training and supramalleolar orthoses use for infants with Down syndrome

干预措施: Treadmill Training (Behavioral)

2

Experimental

Treadmill Training and supramalleolar orthoses use for infants with Down syndrome

干预措施: Supramalleolar Orthoses (Device)

结局指标

主要结局

Pattern of Gross Motor Development

时间窗: monthly; starting when child can pull to stand and ending when the test determined that the child was walking.

Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development.

次要结局

未报告次要终点

研究者

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

Julia Looper

Graduate Student

University of Michigan

研究点 (2)

Loading locations...

相似试验