跳至主要内容
临床试验/NCT03529682
NCT03529682Unknown不适用

The Effects of Circuit Training on Lower Extremities Functionality and Postural Control in Children With Cerebral Palsy

Eastern Mediterranean University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
62
试验地点
1
主要终点
Gross Motor Function will be evaluated

研究概览

简要总结

The aim of our study is to reveal the results of circuit training to be applied to the children with Cerebral Palsy (CP) for improving their muscular strength and trunk control and also to determine their effects in terms of activity limitations and participation limits.

详细描述

According the power analyzes totally 62 children, as 31 per each group, who were diagnosed with Spastic type CP and accepting participation for the study will be included in this study. For every case, socio demographic data and clinical features will be recorded. In the first session their gross motor function, muscular tonus in lower extremities, isometric strength of lower extremity muscles, functional muscular strength of the trunk and the lower extremities, walking speed and main mobility, functional motor performance will be assessed by a physiotherapist. Also satisfaction of children from the exercises, activity and participation level and quality of life will be evaluated. Then Covariant Focused Randomization Method will be used for having similarity in terms of factors such as; age, gender and motor function levels and also for having a balanced and equal case number of control and intervention group. The control group participants will continue to their own previous physiotherapy approaches (Bobath approach, traditional physiotherapy, etc.). "Circuit exercise training" will be given to the intervention group participants during 10 weeks, 3 times a week and that changes 50-60 minutes. At the end of the 10 weeks, the above evaluation parameters will be repeated

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
None

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The children who were diagnosed with Spastic type Cerebral Palsy.
  • •is aged between 6-18,
  • •is on the I,II and III levels according to Gross Motor Function Classification System

排除标准

  • •having any surgical operation related to lower extremities for the last 1 year,
  • •having botulinum toxin injection or intrathecal pump for the last 6 months,
  • •taking a new medicine or medicine change for the last 1 month,
  • •visual, hearing and epilepsy problem,
  • •inability to contınuously attend the exercise program,
  • •mental problem that could not be cooperated.

研究组 & 干预措施

Circuit Training Group

Experimental

Circuit exercise training will be given to the experimental group participants during 10 weeks, 60 minutes in a day and 3 times a week.

干预措施: exercise (Other)

Control Group

Other

The control group participants will continue to their own previous physiotherapy approaches as the same as minimum 3 times a week and total 3 hours.

干预措施: control group (Other)

结局指标

主要结局

Gross Motor Function will be evaluated

时间窗: Change from baseline GMFS at 10 weeks

As for the Gross Motor Function evaluation, the Gross Motor Function Scale (GMFS) will be used and only its D and E sections (standing, walking, running, jumping evaluation parts) will be used. By considering the instructions in to be tested parts in the scale, the case is expected to do the motor functions actively. Without the consideration of the quality of the movement, the case will be observed whether s/he started, was able to continue and completed the movement as well as whether s/he needed any support so that points between 0-3 will be given according to the level. The obtained total score determines the interaction severity of gross motor function

次要结局

  • Isometric strength of bilateral lower extremity muscles and trunk muscles will be evaluated.(Change from baseline isometric strength at 10 weeks)
  • Muscular tonus in lower extremities will be evaluated.(Change from baseline muscular tonus at 10 weeks)
  • Walking speed and main mobility will be evaluated.(Change from baseline walking speed and main mobility at 10 weeks)
  • Functional motor performance will be evaluated.(Change from baseline functional motor performance at 10 weeks)
  • Satisfaction of children from the exercises will be evaluated.(At 10 weeks.)
  • Activity and participation level will be evaluated.(Change from baseline COPM at 10 weeks)
  • Functional muscular strength of the trunk and the lower extremities will be evaluated.(Change from baseline Functional muscular strength at 10 weeks)
  • Quality of life will be evaluated.(Change from baseline LQSC at 10 weeks)

研究者

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

Ünal Aras Değer

Senior Instructor

Eastern Mediterranean University

研究点 (1)

Loading locations...

相似试验