跳至主要内容
临床试验/NCT06838403
NCT06838403招募中不适用

Effect of Masgutova Neurosensorimotor Reflex Integration on Oro-Motor Functional Skills in Children With Cerebral

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Schedual for oromotor Assessment ( SOMA )

研究概览

简要总结

Cerebral palsy (CP) is a disorder of movement and/or posture caused by a non-progressive brain lesion that persists through the lifespan and has a prevalence of more than 2 per 1000 live births (Oskoui et al., 2013). It comprises a heterogeneous group of impairments that may also affect the oral motor functions needed for eating, drinking, swallowing, and articulation (Romano et al., 2017). Dysphagia is a swallowing problem that can influence the safety and efficiency of feeding. This may lead to inadequate nutritional status due to prolonged feeding times (Mishra et al., 2018), stress during mealtimes for the caregiver and/or the child, and impaired growth (Cousino and Hazen, 2013; Stevenson et al, 2006). Estimates of the prevalence of dysphagia in children with CP vary widely due to the different definitions and tools used, variability in severity of CP, and motor type. The prevalence ranges from 21% in a group of 1357 children with CP (Parkes et al., 2010), to 99% in a group of 166 severely affected children with intellectual impairment (Calis et al., 2008). Children with CP commonly have feeding disorders and dysphagia that in many instances place them at risk for aspiration with oral feeding, with potential pulmonary consequences. They also commonly have reduced nutrition/ hydration status and prolonged stressful mealtimes. The specific nature and severity of the swallowing problems may differ, at least to some degree, in relation to sensorimotor impairment, gross and fine motor limitations, and cognitive/ communication deficits. Children with generalized severe motor impairment (for 2

example, spastic quadriplegia) are likely to experience greater swallowing deficits (Calis et al., 2008; Parkes et al., 2010). Oropharyngeal dysphagia may be characterized by problems in any or all phases of swallowing (Arvedson et al., 2019). The oral cavity and pharynx are anatomically separate but functionally integrated, the two regions are involved in complex motor responses that include feeding, chewing, swallowing, speech, and respiration. The multiple sensory receptors that innervate these two regions provide the first link in reflexes that control muscles of the entire head, upper gastrointestinal tract, and airway. Most of the reflexes affect the diversity of muscles that compose the tongue, which is vital to all stages of feeding, and which continually affects the patency of the airway (Miller, 2002). The types of oral and pharyngeal problems that children with CP have include reduced lip closure, poor tongue function, tongue thrust, exaggerated bite reflex, tactile hypersensitivity, delayed swallow initiation, reduced pharyngeal motility and drooling. Impaired oral sensorimotor function can result in drooling that in turn results in impaired hydration (Santos et al., 2012). The Schedule for Oral Motor Assessment (SOMA) is an assessment tool developed for the objective assessment of oral motor function in infants, with proven reliability and validity clinical setting. The SOMA is an assessment tool designed for the objective evaluation of oral-motor functions in children, with proven reliability and validity in infants aged 8-24 months. For the 5 types of test diet, based on the cutting score after assessment in each category, subjects are classified into normal or abnormal oral-motor function groups (Reilly et al., 1995). Oral motor rehabilitation therapy in children with CP aims at reducing or eliminating swallowing disorders and promoting functional feeding (Novak et al., 2020). Some studies suggest that intervention with oral motor therapy (OMT) or oro-motor exercise (OME) has a beneficial effect on functional independence levels and improves the quality of life of patients with feeding and swallowing 3 disorder (FSD) (Sığan et al., 2013; Howe and Wang, 2013). The Masgutova Neurosensorimotor reflex integration (MNRI) Facial Reflex Integration course is directed to the specific primary reaction of facial reflexes and their integration with whole movement development and learning. It arises from the basic Neurosensorimotor Reflex Integration concept that addresses the enhancement of learning through developing movement

详细描述

The purpose of the study is to investigate the effect of MNRI on:

  1. Oro-motor functional skills with different food textures in children with cerebral palsy
  2. Feeding level
  3. Drooling

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

入选标准

  • Children with spastic CP both sexes
  • Age ranged from 1 to 3years and 9 months.
  • Having oromotor dysfunction and drooling.
  • Having dysphagia ranging from level 4 to 6 on FOIS. -

排除标准

  • Congenital problems of mouth and soft plate.
  • Any surgical intervention of head or mouth.
  • Gum Disorders (e.g. gingivitis).

结局指标

主要结局

Schedual for oromotor Assessment ( SOMA )

时间窗: baseline

The SOMA is divided into four main components: * Oral motor challenge categories * Functional areas * Functional units * Discrete oral motor behaviors. Oral motor challenge categories (OMC) refer to the graded textures presented to the infant. There are seven OMC categories: 1. Puree. 2. Semi-solids. 3. Solids. 4. Bottle. 5. Trainer cup. 6. Cup. 7. Crackers.

The Drooling Severity and Frequency Scale (DSFS) is a semi-quantitative assessment of the amount of drooling. It originally was developed to measure frequency and severity of drooling in individuals with cerebral palsy. Subsequently, it has been used in

时间窗: baseline

he DSFS consists of 2 questions. The first question rates severity on a five-point (1-5) scale (never drools, mild, moderate, severe, or profuse). The second question rates drooling on a four-point (1-4) scale (no drooling, occasional, frequent, or constant). The Drooling Score equals the sum of the Severity and Frequency sub-scores (range 2-9).

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

hibatuallah ehab

hebatuallah

Cairo University

研究点 (1)

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