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临床试验/NCT02764775
NCT02764775已完成不适用

Measuring Head Control Changes With 2d Video Analysis After Utilization of the Headpod in Children With Cerebral Palsy and Poor Head Control

Texas Woman's University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2016年3月1日最近更新:
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
14
试验地点
1
主要终点
Change in Head Holding Active Time From Baseline to 6 Months

研究概览

简要总结

Inclusion Criteria: children ages 2 to 14 years with poor head control and non progressive diagnoses. Exclusion criteria: significant change of status i.e. prolonged hospitalization, surgery; inability to tolerate using Headpod. Requires use of Headpod 3x per day for minimum of 15 minutes each time over a 6 month period. Log must be kept documenting usage of the Headpod. Video will be taken to document changes.

详细描述

Requires usage of the Headpod 3x per day for a minimum of 15 minutes each time. Usage required for 6 month period. Log must be kept documenting usage of the Headpod. Video will be taken on initial trial use, 1 week post trial use, at 3 months post utilization of the Headpod and at 6 months post utilization of the Headpod.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •non progressive diagnoses with poor head control

排除标准

  • •recent prolonged hospitalization; surgery, inability to tolerate wearing the Headpod

研究组 & 干预措施

Headed utilization

Experimental

Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time;

干预措施: Headpod (Device)

结局指标

主要结局

Change in Head Holding Active Time From Baseline to 6 Months

时间窗: baseline to 6 months

Active time in seconds holding head upright

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

Julie Brown

PT, DPT, PCS

Texas Woman's University

研究点 (1)

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