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临床试验/NCT05032703
NCT05032703已完成不适用

Effect of Arm Ergometer Versus Stabilization Exercises on Trunk Control and Upper Extremity Functions in Children With Diplegia

Cairo University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年11月18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
42
试验地点
1
主要终点
Trunk control

研究概览

简要总结

The purposes of the current study are to:

Define and compare between the efficacy of arm ergometer versus stabilization exercises on trunk control, hand grip power and upper limb quality of functions in children with diplegia.

详细描述

Studies have shown that the cycle ergometer exercise improves several parameters, such as muscle strength and endurance, along with torso control in sitting position. However, these results are presented only in a small sample. Studies with the use of cycle ergometer in the population with CP are still few and present little information about the physiological effects .Previous studies on children with CP focused on the effect of ergometer on the upper and lower extremities functions. Limited literature is available regarding the effect of arm ergometer on trunk control among this population. The current study will be carried out to define the effect of arm ergometer versus stabilization exercises on trunk control, hand grip power, upper limb function in children with 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
Single (Participant)

盲法说明

Single blind

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age ranges from six to ten years.
  • •Grade of spasticity 1 to 2 according to Modified Ashworth scale.
  • •Level II and III according to gross motor functional classification system.
  • •Level I-III according to manual ability classification system.
  • •Able to follow verbal commands and instructions included in both test and training.

排除标准

  • •Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination).
  • •Structural or fixed soft tissue deformities of the upper extremities.
  • •Neurological or orthopedic surgery in the past 12 months in the upper extremities.
  • •Botox injection in the upper extremities in the past 6 months.

研究组 & 干预措施

Arm ergometer

Experimental

Children in group I will receive strength-endurance protocol of arm ergometer for 30 minutes in addition to the conventional physical therapy program for 30 minutes, per session, three times a week, for three consecutive months.

干预措施: Arm ergometer (Device)

Trunk stabilization exercise

Experimental

Children in group II will receive trunk stabilization exercises for 30 minutes in addition to the conventional physical therapy program for 30 minutes, per session, three times a week, for three consecutive months.

干预措施: Arm ergometer (Device)

结局指标

主要结局

Trunk control

时间窗: 30 minutes

Trunk control measurement scale includes 15 items that assess two main components of trunk control: static and dynamic sitting balance. While the total score is between 0 and 58, higher scores indicate a better level of performance.

Upper extremity functions

时间窗: 30/45 minutes

Quality of upper extremity scale test which consist 34 items in four main domains: dissociated movement, grasp, protective extension, and weight bearing.

次要结局

  • Hand grip strength(5 minutes)

研究者

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

Reham Nafea Mohie El Din

Dr Reham Nafea master degree, faculty of physical therapy

Cairo University

研究点 (1)

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