跳至主要内容
临床试验/NCT06747078
NCT06747078已完成不适用

The Effect of Core and Balance Exercises on Gait, Balance and Quality Of Life in Children With Cerebral Palsy: A Comparative Study

Pamukkale University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年8月25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
36
试验地点
2
主要终点
Pediatric Balance Scale (PBS)

研究概览

简要总结

In this study, considering the importance of walking and balance functions in improving the quality of life and achieving independence in children with cerebral palsy, it was aimed to examine whether core stabilization exercises specifically designed for children with cerebral palsy have an impact on improving balance and walking functions as well as quality of life. Additionally, the study sought to determine whether this approach has superiority over conventional balance exercises.

详细描述

Children with cerebral palsy included in the study were randomized into three groups using block randomization based on age, type of cerebral palsy and the Gross Motor Function Classification System (GMFCS). Children with cerebral palsy aged 7-18 years were included. Group 1 (study group, n=12) received neurodevelopmental therapy (NDT) combined with core stabilization exercises (CSE). Group 2 (study group, n=12) received NDT combined with balance exercises (BE). The control group (n=12) received only NDT. Treatments were conducted for 60 minutes per session, three times a week, over 8 weeks, for a total of 24 sessions, with an equal duration across groups. Participants' balance was evaluated using the Pediatric Balance Scale (PBS) and the SportKat 550® device. The Trunk Involvement Scale (TIS) was used to measure trunk impairment, the Six-Minute Walk Test (6MWT) to assess functional mobility and walking capacity and the Pediatric Outcome Data Collection Instrument (PODCI) to evaluate quality of life. All assessments were performed by the same physiotherapist before and after treatment

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
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Cases between the ages of 7-18
  • Cases with GMFCS level I and II
  • Cases diagnosed with hemiparetic and diparetic CP

排除标准

  • Cases with levels III, IV and V according to GMFCS
  • Having an intellectual disability that would prevent participation in assessment and exercise training
  • Having had Botulinum Toxin (BOTOX) Type A application within the last 6 months
  • Having undergone any surgical operation within the last 6 months
  • Hearing and vision problems

结局指标

主要结局

Pediatric Balance Scale (PBS)

时间窗: eight weeks

The Pediatric Balance Scale is used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.

SportKat550 Kinesthetic Ability Trainer (SportKAT 550)

时间窗: eight weeks

The SportKAT-550® device used to determine postural sway consists of sensors that detect sway and is also a balance platform. There is a digital screen in front of the platform to provide feedback to the person on it. The person on the platform is asked to hold the "X" mark on the digital screen in the center while the static balance test is performed. A score of 500 or lower than 500 in the static balance measurement indicates that the balance is good and the postural sway is low.For dynamic balance, a score between 750-950 is excellent, and a score between 1350-1550 indicates good balance.

Pediatric Outcome Data Collection Instrument (PODCI)

时间窗: eight weeks

It is a widely used scale to determine quality of life, functional health status and participation in children with cerebral palsy.The test is a Likert type scale and consists of 5 parts.PVTA, which has validity and reliability in Turkish, is scored between 0-100.

次要结局

  • Six Minute Walk Test (6MWT)(eight weeks)
  • The Trunk Involvement Scale (TIS)(eight weeks)

研究者

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

Hatice Özoymak Akçin

Principal Investigator MSc. Physiotherapist

Pamukkale University

研究点 (2)

Loading locations...

相似试验