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临床试验/NCT04937439
NCT04937439Unknown不适用

Effect of Segmental Trunk Stability Training on Sitting and Upper Limbs Functions in Children With Spastic Cerebral Palsy

Horus University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
45
试验地点
1
主要终点
Assessing the change in upper limb functions

研究概览

简要总结

The study aims to:

  1. Investigate the effect of segmental trunk stability training on sitting in children with spastic CP.
  2. Investigate the effect of segmental trunk stability training on upper limbs functions in children with spastic CP.

详细描述

Postural dysfunction is one of the most limiting factors in children with CP. It restricts reaching skills and in turn reduces participation in activities of daily living.

The trunk plays a key role in maintaining the postural control mechanism and also in the organization of balance reactions in this developmental process. The trunk control is also required for a stable base of support which is necessary to execute functional activities for limb movements.

The optimal level of trunk support for a child with spastic CP still remains unknown. Thus, providing intermediate levels of trunk stabilization would be a better solution than providing full support in children with CP. Innovation is necessary to improve outcomes for children with moderate to- severe CP who are at level IV and V on GMFCS. However, these children are often excluded from posture research . Very little research has examined postural constraints in children with moderate-to-severe CP.

As there is a lack of tools used in precise trunk stabilization during training, a further researches are needed. Recently, a special attention has been given to the segmental trunk control and its effects on improvement of gross and fine motor skills. Most of previous studies have been applied during segmental fixation of the trunk at multiple levels from static position either sitting or standing. In the present study, the effect of external segmental stabilization of the trunk at selected parts will be monitored during the active training and participation of the child.

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
2 Years 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with spastic CP, their chronological age will be ranged from 2 years to 4 years.
  • Their level of motor function will be 4 or 5 according to Gross Motor Function Classification System - Expanded and Revised
  • The degree of spasticity for these children will ranged from grade 1 to 2 according to Modified Ashworth Scale
  • All children's level of segmental trunk control will be level 3 according to Segmental Assessment of Trunk Control
  • They will be able to follow instructions during evaluation and treatment.

排除标准

  • Any child with the following criteria will be directly excluded from the evaluation for the consistency of the sample and statistically obtained results:
  • Surgical interference in upper limbs and/or spine that may restrain the child performance during activities.
  • Orthopedic problems or fixed deformities in the vertebral column and/or upper extremities.
  • Uncontrolled seizures.
  • Visual or hearing impairment.

结局指标

主要结局

Assessing the change in upper limb functions

时间窗: Baseline and after 6 months post intervention

Assessment via using Quality of Upper Extremity Skills Test (QUEST) is a 34-item observational criterion-referenced test consisting of four subsections: dissociated movement, grasp, weight bearing, and protective extension. Items are related to quality of movement, not to chronological age.

Assessing the change in gross motor function - sitting domain

时间窗: Baseline and after 6 months post intervention

Assessment via using gross motor functional measurement scale is an assessment tool designed and evaluated to measure changes in gross motor function over time or with intervention in children with cerebral palsy.

Assessing the change in segmental trunk control

时间窗: Baseline and after 6 months post intervention

Assessment via using Segmental Assessment of Trunk Control (SATCo) is a validated and internationally recognized measurement tool.

次要结局

未报告次要终点

研究者

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

Mohamed Arafat

Principal investigator

Horus University

研究点 (1)

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