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临床试验/NCT06930053
NCT06930053已完成不适用

Effect of Action Observation Training Versus Core Stability Training on Hand Functions in Children With Hemiplegic Cerebral Palsy

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年5月9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
52
试验地点
1
主要终点
evaluates the quality of upper extremity skill function through 33 activity items of 4 domains: dissociated movement consists of 19 items, grasp consists of 6 items, weight-bearing consists of 5 items, and protective extension consists of 3 items

研究概览

简要总结

This study will be conducted to compare between the effectiveness of Action observation therapy (AOT) and core stability training and the combination of Action observation therapy (AOT) and core stability training on hand function in hemiplegic CP

详细描述

Cerebral palsy (CP) refers to a collection of permanent mobility and postural impairments that are caused by non-progressive disruptions in the fetal or infant brain throughout development. Children with CP have motor abnormalities that are commonly accompanied by sensory and cognition disorders as well as seizures and secondary musculoskeletal difficulties. Cerebral palsy can be broken down into four basic categories based on the degree of activity restriction: motor abnormalities, accompanying impairments, anatomical and neuroimaging results, and etiology and timing of motor problems . It is a chronic and disabling childhood condition that occurs in 1.5/1,000 to 3/1,000 live births .Pregnancy age under 20 years, birth weight under 2500 gramme , risk factors related to the mother, pregnancy variables (placental dislodgement ,twining), and fetal factors are all examples of CP causes or risk factors(bradycardia, fetal malformation, poor fetal growth) As a well-known neurodevelopmental disorder, CP can begin in early childhood and last throughout life. For example, non-progressive abnormalities in the growing fetus or infant brain might cause activity limitations, poor sensation and cognition as well as mobility and posture issues .

Three out of every 1000 children with CP have a movement and coordination disorders which are compromised in people with CP due to both decreased brain control and secondary alterations in muscle characteristics. It is difficult to quantify the degree and functional significance of changes in muscle characteristics for individual patients with CP, which makes therapy planning difficult .

Early intervention for the upper limb in hemiplegia remains challenging, though progress is being made. It was concluded that the difficulties of outcome assessment in the youngest infants and children, which make evaluation of interventions very difficult. The diversity of the population under study, in terms of lesion type, differences in post-lesional reorganization, and the degree to which other factors such as vision, sensation, and cognitive ability impact on hand function, must also be considered .

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

The participants will not know the details of the intervention of the other groups

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Their age will be ranged from four to eight years.
  • •Their grade of spasticity will be from 1 to 1+ according to Modified Ashworth scale .
  • •They will be on Level I and II according to Gross Motor Functional Classification System (GMFCS) .
  • •The child will be able to follow verbal commands and instructions.

排除标准

  • •- The children will be excluded if they have one of the following:
  • •history of orthopedic surgery in the affected upper limb
  • •Botox injection in the upper limb in the past 6 months or planned to have one during study time
  • •4-Fixed deformities or contructures in spine. 5- A history of epileptic seizure and cardiac or respiratory problems. 6- Severe hearing and visual defect.

研究组 & 干预措施

Treatment protocol in Group A, Core stability training

Active Comparator

The study group will receive core stability exercises, which consist of three levels. Each level took 4 weeks. The difficulty of each level varies in proprioception, balance, and stability as it started from exercising on a stable surface "mat" and ended with unstable surface "physioball". The first simple level involves supine abdominal draw (3 sets per 20 repetitions), abdominal draw-in with a double knee to chest (3 sets/20 repetitions), and supine twist (3 sets per 20 repetitions). The second medium level involves pelvic bridging (3 sets per 3-5 repetitions) and twists with a medicine ball (3 sets per 10-20 repetitions). The third difficult level involves bridging with head-on physioball holding this position for 3-5 seconds, then slowly relaxing (3 sets per 10-20 repetitions), and prone bridging (3 sets per 3-repetitions). There was a 30-second rest between sets . The program will be applied 30 minutes a day for 3 days a week for 12 weeks. in addition to 30 minutes of a standar

干预措施: Core stability training (Other)

Group B, Action observation therapy

Active Comparator

The examined group got 30 minutes of a standard,selected physical therapy program in addition to 30 minutes of AOT on the upper limb (total session time: 1 hour), 3 sessions per week for three consecutive months (total therapy time: 3 hours/week). Action observation was executed with therapist guidance and repeated practice (3 repetitions for each task). The child has been requested to perform the watched task with the same tool after observing a 3-minute video for each task on an adjustable monitor screen positioned one meter infront of him or her from forward, sideways, and backward directions. The therapist sat beside the child to provide verbal comments during the excursion and to guide the child's movement

干预措施: Action observation therapy (Other)

Group c, combination of Action observation therapy and core stability training .

Active Comparator

Group c, combination of Action observation therapy and core stability training .

干预措施: combination of Action observation therapy and core stability training . (Other)

结局指标

主要结局

evaluates the quality of upper extremity skill function through 33 activity items of 4 domains: dissociated movement consists of 19 items, grasp consists of 6 items, weight-bearing consists of 5 items, and protective extension consists of 3 items

时间窗: After 12 week

The Quality Upper Extremity Skill Test (QUEST)

Assessment of the grip strength

时间窗: After 12 week

Assessment of the grip strength by using Hand and Held Dynamometer:

Measure hand function for activities of daily living. It has 7 items include: writing, turning over 3-by-5 inch cards, picking up small common objects, simulated feeding, stacking checkers, picking up large light objects and picking up large heavy object

时间窗: After 12 week

Jebsen Hand Function Test

次要结局

未报告次要终点

研究者

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

Ahmed Abdou Ragab Abdou

Demonstrator

Kafrelsheikh University

研究点 (1)

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