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临床试验/NCT07114731
NCT07114731已完成不适用

The Comparison of the Effects of Synchronous and Asynchronous Action Observation Therapy on Balance, Walking and Functional Capacity in Children With Cerebral Palsy

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年8月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Gross Motor Function Measure - 88 (GMFM-88) - Dimensions D and E

研究概览

简要总结

The aim of this study is to compare the effects of synchronous and asynchronous action observation therapy (AOT) on balance, gait, and functional capacity in children with cerebral palsy (CP). CP is a neurodevelopmental disorder characterized by impairments in motor skills, particularly motor control and postural balance. By examining the contributions of synchronous (real-time) and asynchronous (delayed) AOT methods to motor performance, this study seeks to identify the most effective therapeutic approach for this population.

详细描述

Cerebral palsy (CP) is defined as a non-progressive neurological disorder that arises during fetal development, the neonatal period, or early childhood and results in permanent motor impairments. Lesions in the central nervous system of children with CP lead to a range of musculoskeletal, neuromuscular, and sensory system problems, causing postural abnormalities, balance and coordination deficits, and limitations in mobility. These impairments significantly reduce independence in activities of daily living.

Various therapeutic approaches are utilized in the rehabilitation process to improve the functional independence of children with CP. According to the International Classification of Functioning, Disability and Health (ICF), rehabilitation interventions should be grounded in neuroplasticity-based principles to maximize functional outcomes. One such neuroplasticity-based approach that has gained increasing attention in recent years is Action Observation Therapy (AOT).

AOT is based on the mirror neuron theory, which posits that observing an action activates similar neural regions in the cerebral cortex as performing the action itself. This simultaneous activation facilitates action understanding, imitation, and motor learning, suggesting that AOT may be an effective intervention to enhance motor function in individuals with CP. Improving motor functions in children with CP is crucial to enhancing their participation in daily life activities and overall quality of life. In addition to conventional physiotherapy interventions, AOT has emerged in recent years as an effective rehabilitation strategy that supports neuroplasticity. AOT facilitates motor learning and skill acquisition by targeting the brain's mirror neuron system.

Although there is substantial evidence in the literature demonstrating that AOT improves upper extremity functions, studies systematically comparing its effects on balance, gait, and general functional capacity remain limited. In particular, the differential effects of synchronous and asynchronous AOT applications on various motor outcomes have not yet been thoroughly investigated. Understanding the mechanisms of action of these two approaches may contribute to the development of more individualized and tailored treatment programs for children with CP.

Moreover, the low cost and easy applicability of AOT increase its potential for clinical use. Therefore, the findings of this study could enhance the effectiveness of rehabilitation programs, offering more accessible treatment alternatives for both healthcare professionals and families. To address this gap in the literature, the present study aims to comprehensively investigate the effects of synchronous and asynchronous AOT on motor functions in children with CP.

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)

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

入选标准

  • Voluntary participation of both the child and their family in the study
  • Diagnosis of cerebral palsy with spastic clinical type, including hemiparetic and diparetic distribution
  • Age between 6 and 18 years
  • Classified as Level I or II according to the Gross Motor Function Classification System (GMFCS)
  • Ability to comply with exercise interventions (based on medical report indicating normal mental level or "mild mental retardation")
  • Ability to understand and speak Turkish

排除标准

  • Presence of spasticity ≥3 in lower extremity muscle groups as measured by the Modified Ashworth Scale
  • Inability to cooperate with verbal commands
  • Presence of visual or hearing impairments
  • Diagnosis of epilepsy or current use of antiepileptic medications
  • Presence of joint contractures
  • Botulinum toxin injection to the lower extremities within the past 6 months
  • Undergoing orthopedic surgery within the past 6 months
  • Presence of any additional systemic or neurological diseases
  • Missing three consecutive rehabilitation sessions

研究组 & 干预措施

Neurodevelopmental treatment (NDT) + Synchronous Action Observation Therapy (AOT) Group

Experimental

Participants in this group will receive a 20-minute Neurodevelopmental Training (NDT) session followed by synchronous Action Observation Therapy (AOT). The AOT component consists of four video modules:

  1. Sitting position + Sit-to-Stand exercises
  2. Weight-shifting exercises
  3. Balance exercises
  4. Walking exercises

Participants will observe the videos in real-time and perform the movements simultaneously. The intervention will last for 8 weeks, with sessions conducted twice weekly for 45 minutes each.

干预措施: Synchronous Action Observation Therapy (Other)

Neurodevelopmental treatment (NDT) + Asynchronous Action Observation Therapy (AOT) Group

Experimental

Participants in this group will receive the same 20-minute NDT session followed by asynchronous Action Observation Therapy (AOT). In this group, participants will first watch each of the four video modules, then perform the exercises afterward (i.e., not in real time).

The intervention will last for 8 weeks, with sessions conducted twice weekly for 45 minutes each.

干预措施: Asynchronous Action Observation Therapy (Other)

结局指标

主要结局

Gross Motor Function Measure - 88 (GMFM-88) - Dimensions D and E

时间窗: 2 days before treatment and 8 weeks

The GMFM-88 is a standardized observational instrument designed to measure changes in gross motor function in children with cerebral palsy. The scale consists of five dimensions: (A) Lying and rolling (B) Sitting (C) Crawling and kneeling (D) Standing (E) Walking, running, and jumping For this study, only Dimensions D and E will be assessed to evaluate standing and locomotor abilities. Each item is scored based on the child's ability to perform specific motor tasks. Scores can be calculated for each dimension separately as well as combined for a total score.

Pediatric Balance Scale (PBS)

时间窗: 2 days before treatment and 8 weeks

The pediatric balance scale is a modified version of the Berg balance scale and is used to evaluate the functional balance ability of school-age children. The scale consists of 14 items, scored from 0 (lowest function) to 4 (highest function), with a maximum score of 56.

次要结局

  • Gross Motor Function Classification System(2 days before treatment)
  • Gillette Functional Assessment Questionnaire (FAQ)(2 days before treatment and 8 weeks)
  • 10-Meter Walk Test (10MWT)(2 days before treatment and 8 weeks)
  • Five Times Sit to Stand Test(2 days before treatment and 8 weeks)
  • Functional Reach Test (FRT)(2 days before treatment and 8 weeks)
  • Timed Get Up and Go Test (TUG)(2 days before treatment and 8 weeks)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Iremnur Gunhan

Physiotherapist

Istanbul University - Cerrahpasa

研究点 (1)

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