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临床试验/NCT06190418
NCT06190418已完成不适用

Comparative Effects of Loaded and Unloaded Sit to Stand Strengthening Exercises on Functional Strength and Energy Expenditure in Children With Cerebral Palsy

Riphah International University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Energy Expenditure

研究概览

简要总结

Cerebral palsy(CP) is non-progressive disorder, undergo mishap to the developing brain and it affect a person's ability to move and maintain balance and posture. Old name of CP is "Little's disease". Cerebral means having to do with the brain. Palsy means weakness or problems with using the muscles. In Spastic diplegic, muscle stiffness is mainly in the legs, with the arms less affected or not affected at all. The most common cause of spastic diplegia is Periventricular leukomalacia, more commonly known as neonatal asphyxia or infant hypoxia-a sudden in-womb shortage of oxygen-delivery through the umbilical cord. Strength exercise is any activity that makes your muscles work harder than usual.

The significance of this study is that it will define whether loaded or unloaded sit to stand strengthening exercises have good effect on muscle strength and energy expenditure in diaplegic CP. This will be a randomized clinical trial, data will be collected from District Head Quarter DHQ hafizabad. Study will be conducted on 32 patients. Inclusion criteria of this study is spastic diplegic CP children with age between 6 to 12 years, with GMFCS level 1 and 2 and those who are able to stand up from chair independently and maintain standing for more than 5 seconds without falling will be included.Diplegic CP children who had not received any strengthening exercise program in past 3 months and those less than 20 degrees limitation in passive range of motion in hip flexion will be included. Those diplegic spastic CP who have orthopedic intervention such as selective dorsal rhizotomy or botolinum toxin injection to lower extremities within past six months and orthopedic conditions or medical problems that prevented children from participating in exercises will be excluded. Group A will be provided with loaded sit to stand strengthening exercises. 1 repetition maximum(1-RM) will be used as loaded sit to stand test. Group B will be provided with unloaded sit to stand strengthening exercises. Pre and post session lower limb functional strength will be measured by performing functional strength tests while lower limb muscular strength will be measured via modified sphygmomanometer and physiological cost index will be measured to rule out energy expenditure.

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, Investigator)

入排标准

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

入选标准

  • Spastic diplegic cerebral palsy
  • Age between 6 to 12 years
  • Children with GMFCS level I and II
  • Able to stand up from chair independently and maintain standing for more than 5 second without falling.
  • Had not received any strengthening exercise program in past 3 months
  • Parental commitment to allow participation without altering current activity

排除标准

  • Participants with epileptic history and lower limb contractures are excluded
  • Those who are unable to follow verbal command
  • Have orthopedic intervention such as selective dorsal rhizotomy or botolinum toxin injection to lower extremities within past 6 months
  • Orthopedic condition or medical problems that prevent children from participating in exercise

结局指标

主要结局

Energy Expenditure

时间窗: Baseline and 6th week

To find out energy expenditure, physiological cost index (PCI) will be measured. PCI will be calculated by using the following formula: PCI (beats/meter)= Final heart rate -Resting Heart Rate /speed of walking

Muscle Strength

时间窗: Baseline and 6th week

Muscle strength will be assessed by Bag method of Modified Sphygmomanometer

次要结局

  • Functional Strenght -Lateral Step-up Test (on a 20 cm bench)(Baseline and 6th week)
  • Functional Strenght -Sit-to-Stand (from 90 flexion of the knee and hip to standing position)(Baseline and 6th week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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