跳至主要内容
临床试验/NCT06942364
NCT06942364已完成不适用

The Effect of Action Observation Therapy on Balance and Lower Extremity Function in Children With Hemiparetic Cerebral Palsy

Fatih Tekin2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
Fatih Tekin
入组人数
20
试验地点
2
主要终点
Timed Up and Go Test

研究概览

简要总结

Background:

Action Observation Therapy (AOT) leverages the mirror neuron system to enhance motor learning and is anticipated to improve upper extremity function in children with cerebral palsy. However, its effects on balance, lower extremity function, and gait performance in children with hemiparetic cerebral palsy remain underexplored. The planned study aims to evaluate whether the addition of AOT to conventional physiotherapy will positively influence balance, lower extremity function, and gait performance in this population.

Objective:

The study is designed to assess the efficacy of incorporating AOT as an adjunct to conventional physiotherapy in improving balance, lower extremity function, and gait performance in children with hemiparetic cerebral palsy.

Methods:

A patient cohort consisting of children with hemiparetic cerebral palsy (GMFCS levels I and II) is planned to be assembled.

It is expected that a total of 20 patients will be recruited and then randomly allocated into an experimental group and a control group.

The experimental group is scheduled to receive conventional physiotherapy in addition to AOT sessions, while the control group is planned to receive conventional physiotherapy only.

The intervention period is planned for 6 weeks, during which both groups will participate in 12 physiotherapy sessions.

Additionally, the experimental group is scheduled to undergo AOT sessions twice weekly, with each session lasting 30 minutes.

Outcome measures to be employed will include the Timed Up and Go (TUG) test, Pediatric Balance Scale, Five-Step Stair Climbing and Descending Test, and the 6-Minute Walk Test (6MWT).

This study is expected to systematically evaluate the potential benefits of adding AOT to standard physiotherapy regimens for enhancing balance, lower extremity function, and gait performance in children with hemiparetic cerebral palsy.

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 (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Diagnosed hemiparetic type of cerebral palsy

排除标准

  • Any other types of cerebral palsy

结局指标

主要结局

Timed Up and Go Test

时间窗: This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.

The Timed Up and Go (TUG) Test is a simple and widely used clinical tool to assess a person's mobility, balance, and risk of falling. It involves timing a person as they rise from a standard chair, walk a distance of 3 meters, turn around, walk back to the chair, and sit down. The total time taken to complete this sequence is recorded, with shorter times generally indicating better functional mobility. The TUG Test is commonly used in various populations, including older adults and individuals with neurological conditions such as stroke or cerebral palsy, to evaluate progress during rehabilitation or to identify individuals at risk of falls. It is valued for its ease of use, minimal equipment requirements, and ability to reflect real-world functional movements.

Pediatric Balance Scale

时间窗: This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.

A modified version of the Berg Balance Scale for children, the PBS consists of 14 items (maximum score 56). It assesses functional balance through activities such as sitting-to-standing, standing, transfers, stepping, single-leg stance, turning, bending, and reaching. The scale has demonstrated strong correlations with other functional measures in children with CP

Five-Step Stair Climbing and Descending Test

时间窗: This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.

This test evaluates functional mobility parameters including walking speed, strength, active joint range, and balance. Children are instructed to ascend and descend a 5-step staircase without pausing. The better of two trials is recorded; a shorter completion time indicates superior functional performance

6-Minute Walk Test

时间窗: This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.

Originally developed by Balke (1963), the 6MWT measures the distance walked in 6 minutes, reflecting the child's functional capacity for daily activities. In children with CP, typical distances range from 334 to 455 meters, varying according to sex, age, height, weight, and step length

次要结局

未报告次要终点

研究者

发起方
Fatih Tekin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fatih Tekin

Assist. Prof.

Pamukkale University

研究点 (2)

Loading locations...

相似试验