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临床试验/NCT01952496
NCT01952496已完成不适用

Load Experienced While Using a Stander in Children With Cerebral Palsy

Gillette Children's Specialty Healthcare2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2014年2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
3
试验地点
2
主要终点
Bone Mineral Density

研究概览

简要总结

The goal of this project is to design and validate a force-measuring platform that will measure the magnitude and duration of the load experienced by the lower extremities of individuals with a neuromuscular disability who use a stationary assisted standing device to increase their Bone Mineral Density.

详细描述

Non-ambulatory children with a neuromuscular disability are at significant risk for poor bone health as reflected by low bone mineral density (BMD) and increased propensity to fracture. In large part, this is due to abnormally low levels of load experienced by the skeleton. A common approach for increasing BMD is to stimulate the musculoskeletal system by increasing the amount and duration of weight-bearing in the lower extremities. For non-ambulatory individuals, this typically takes the form of using an assisted standing device to enable the child to spend time in a standing position so that their lower limbs can experience some degree of body weight. Some of these physical interventions result in varying degrees of improvement in BMD, and some do not. This lack of clarity in outcomes may result from a failure to objectively measure the magnitude and duration of the load experienced by the lower extremities. A lack of change in BMD may be due to the extremities experiencing only a fraction of the body weight due to load-sharing with the assistive device, or to an inadequate duration of standing time. The goal of this project will be to design and validate a force-measuring platform that will measure the magnitude and duration of the load experienced by the lower extremities of individuals with a neuromuscular disability who use a stationary assisted standing device to increase their BMD.

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
— 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •< 18 years old
  • •Diagnosed with Cerebral Palsy (CP)
  • •Treated at Gillette Children's Specialty Healthcare
  • •Gross Motor Function Classification System level of IV or V (non-ambulatory without assistance)
  • •Participating in a standing program using a stationary assisted standing device
  • •Parent/Guardian willing and able to give consent

排除标准

  • 未提供

研究组 & 干预措施

Force-measuring platform

Other

A force-measure platform will be placed under each foot of the subject to record the time course of load borne by each of the lower extremities during weight-bearing training in an assisted standing device.

Intervention: Assisted Standing Treatment Program. Assisted standing treatment program will include at least 2 hours a day, 5 days a week (a total of at least 10 hours a week) for a period of ~9 months.

干预措施: Assisted Standing Treatment Program (Other)

结局指标

主要结局

Bone Mineral Density

时间窗: 12 months

Bone Mineral Density will be measured via dual energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) scans.

次要结局

  • Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) questionnaire(12 months)
  • Weight (load)experienced by lower extremities(12 months)
  • Duration of standing treatment session(s) (time)(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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