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临床试验/NCT05606926
NCT05606926尚未招募不适用

Effect of Whole Body Vibration With Weighted Vest on Motor Function in Children With Spastic Diplegia

Cairo University0 个研究点目标入组 30 人开始时间: 2023年1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
尚未招募
入组人数
30
主要终点
Gross motor function

研究概览

简要总结

Whole body vibration has been widely used in rehabilitation of individuals with disabilities as well as children with cerebral palsy. Previous studies have demonstrated the efficacy of Whole body vibration on balance, gross motor function, spasticity and bone density in children with cerebral palsy. However, adding extra weight during Whole body vibration for children with cerebral palsy as a means of enhancing the potential effects of Whole body vibration is unknown. Therefore, the aim of this study is to examine the effect of Whole body vibration with weighted vest on trunk control, balance and gross motor function in children with spastic diplegia.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Their age will range from 8-12 years, from both sexes.
  • •Level II and III of gross motor functional classification system
  • •Grade 1 and 1+ spasticity according to the Modified Ashworth Scale
  • •Ability to understand and follow simple verbal instruc

排除标准

  • •Uncontrolled epilepsy.
  • •Mental retardation or autistic features.
  • •Medication changes that could affect muscle strength or tone
  • •Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination),
  • •Structural or fixed soft tissue deformities of the lower and/or upper extremities.
  • •Neurological or orthopedic surgery in the past 12 months in the lower and/or upper extremities.
  • •Botox injection in the lower and/or upper extremities in the past 6 months.

研究组 & 干预措施

Group I

Other

15 Children with spastic diplegia in this group will a designed physical therapy program for 60 minutes per session in addition to WBV for 10 minutes, three times a week, for three consecutive months.

干预措施: physical therapy program (Other)

Group I

Other

15 Children with spastic diplegia in this group will a designed physical therapy program for 60 minutes per session in addition to WBV for 10 minutes, three times a week, for three consecutive months.

干预措施: whole body vibration (without extra weight vest) (Other)

Experimental group

Experimental

15 Children with spastic diplegia in this group will receive the same designed physical therapy program while WBV will be conducted while wearing a weighted vest.

干预措施: physical therapy program (Other)

Experimental group

Experimental

15 Children with spastic diplegia in this group will receive the same designed physical therapy program while WBV will be conducted while wearing a weighted vest.

干预措施: whole body vibration (with weight vest) (Other)

结局指标

主要结局

Gross motor function

时间窗: three months

The Gross motor function measure-88 will be used to assess motor function in 88 items across five dimensions: (a) lying and rolling, (b) sitting, (c) crawling and kneeling, (d) standing, and (e) walking, running and jumping. dimensions D and E will be assessed in the current study The assessment of each item will be conducted carefully and scored according to the scale scoring key (scale from 0-3) with total score 100 and higher score represent better performance

Trunk control

时间窗: three months

The Trunk Control Measurement Scale is used to assess trunk control and consists of static and dynamic sitting balance in children aged 8 to 15 years with spastic CP

balance

时间窗: three months

Human computer balance system will be used to assess balance to assess center op pressure and limits of stability

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

Amira Mahmoud Abd-elmonem

Assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university

Cairo University

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