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临床试验/NCT05106829
NCT05106829Unknown不适用

Effect of Treadmill Training Combined With Ankle Weights on Balance in Spastic Cerebral Palsied Children.

Beni-Suef University0 个研究点目标入组 40 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
Balance

研究概览

简要总结

The purpose of the study is to investigate the effect of treadmill training combined with ankle weights on balance in spastic cerebral palsied children.

详细描述

Cerebral palsy defined as a non-progressive, non-hereditary lesion of the cerebral cortex resulting in postural and motion disturbances. Spastic cerebral palsied children have deficits in the selection of appropriate sensory inputs for postural control. Balance is a complex motor skill often referred to as postural control which is the ability to maintain equilibrium in a gravitational field by keeping or returning the center of body mass over the base of support. Treadmill gait training supporting the body weight which simulates walking on flat land is prescribed in rehabilitation of spastic cerebral palsy to improve their balance or to reduce their gait disturbance. Several studies support the use of ankle weights during treadmill gait training to reinforce muscle strength and, improve the symmetry of gait while, there is no research conducted on balance in spastic cerebral palsied children. Hence, there is need to study the effect of treadmill training combined with ankle weights on balance in spastic cerebral palsied children.

Fourty children with spastic hemiparetic cerebral palsied children (based on power analysis) from both sexes (6-9 years) will be recruited from different private pediatric physical therapy clinics. They will be divided randomly into control group (20 children) and study group (20 children). Control group will be participated in designed physical therapy program in addition to gait training on treadmill with full weight bearing without using of ankle weights. Study group will be participated in the same designed physical therapy program received by the control group in addition to gait training on treadmill with ankle weights on the affected side ankle.

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
Double (Participant, Outcomes Assessor)

盲法说明

By random generator

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 1-Children ages will be ranged from 6 to 9 years old. 2-Confirmed diagnosis of hemiparetic cerebral palsy by a pediatric neurologist.
  • 3-Spasticity grades ranged from 1 to +1 according to modified Ashworth. 4-Balance problems (frequent falling especially when increasing speed or walking on uneven surface) based on the Biodex stability system.
  • 5-Independent standing and walking. 6-Ability to follow simple verbal commands and instructions

排除标准

  • Auditory or visual defects or any perceptual defects.
  • Fixed deformities on both upper or/ lower limbs.
  • Botox injection.
  • Cardiovasucular disease.
  • Surgery within the previous 24 months.

结局指标

主要结局

Balance

时间窗: Up to 8 weeks

Biodex Stability System will be used to measure overall stability index, anteroposterior stability index and mediolateral stability index.

Muscle strength

时间窗: Up to 8 weeks

Handheld dynamometer (Lafayette) will be used to record dorsiflexors force in pounds (Lbs)

次要结局

  • Functional balance assessment(Up to 8 weeks)

研究者

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

Eman Wagdy

lecturer

Beni-Suef University

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