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临床试验/NCT00295295
NCT00295295已完成2 期

Mechanical Intervention in Children With Cerebral Palsy

Children's Hospital Los Angeles1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2004年9月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
34
试验地点
1
主要终点
Vertebral bone density

研究概览

简要总结

Cerebral palsy is a group of disorders characterized by lack of coordination in the muscles, loss of movement, and speech disturbances. These disorders are caused by injuries to the brain that occur during fetal development or near the time of birth. The purpose of this study is to determine the effects of high frequency, low magnitude vibration on bone and muscle in children with cerebral palsy.

详细描述

The extent of bone mass built up during childhood and adolescence is the most important determinant of osteoporosis later in life. Some disabled children, such as those with cerebral palsy, are particularly vulnerable to low bone mass accumulation due to decreased mobility and weight-bearing. These children also have poor muscle strength and control, which limits function and contributes to the lack of mechanical stimulation needed to build bone mass. The most common treatment for these children is physical therapy, which is time- and labor-intensive and may not be adequately available to them. Whole body vibration has shown promise as an alternative method for stimulating increases in bone mass and improvements in muscle. The purpose of this study is to evaluate the effects of high frequency, low magnitude vibration on bone and muscle in children with cerebral palsy. This intervention may be useful as a noninvasive, nonpharmacological treatment for low bone mass and poor muscle function in these children.

This study will last 1 year. All participants will visit the hospital 3 times, at study entry and Months 6 and 12. At each visit, height and weight will be measured, muscle strength and balance will be tested, and bones and muscles in the spine and lower leg will be imaged with computed tomography (CT), a special x-ray machine. Participants will be randomly assigned to one of two groups. For this study, all participants will be asked to stand for 10 minutes every day for 1 year. For Group 1, a vibrating platform will be used for the 10-minute standing sessions during the first half of the study but not during the second half of the study. For Group 2, this will be reversed and the vibrating platform will not be used during the first half of the study but will be used during the second half of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of cerebral palsy
  • •Low vertebral bone density
  • •Able to stand for 10 minutes with handheld support
  • •Parent or guardian willing to provide informed consent

排除标准

  • •Surgery, casting, or receipt of botulinum toxin in the 12 months prior to study entry
  • •Planned surgery, casting, or receipt of botulinum toxin in the 12 months after study entry
  • •Metal rods or plates in tibia or lumbar spine
  • •Severe scoliosis (greater than 20 degrees) or bowing of tibia
  • •Medical condition other than cerebral palsy affecting bone or muscle
  • •Require corticosteroids or seizure medication (phenytoin)

研究组 & 干预措施

Vibration

Experimental

High frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc.

干预措施: High frequency, low magnitude vibration (Device)

Standing

Active Comparator

Standing 10 min/day

干预措施: Standing (Other)

结局指标

主要结局

Vertebral bone density

时间窗: Measured at Month 12

Tibia cross-sectional area

时间窗: Measured at Month 12

Tibia bone density

时间窗: Measured at Month 12

次要结局

  • Balance test(Measured at Month 12)
  • Calf muscle strength(Measured at Month 12)

研究者

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

Tishya Wren

Principal Investigator

Children's Hospital Los Angeles

研究点 (1)

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