Kinesio Taping Versus Neuromuscular Electrical Stimulation on Dysphagia in Children With Bilateral Spastic Cerebral Palsy. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Oral Motor Skills
研究概览
简要总结
The purpose of this study will be to compare the effect between kinesiotaping and neuromuscular electrical stimulation on dysphagia in children with bilateral spastic cerebral palsy.
详细描述
Dysphagia is one of the most common feeding and swallowing problems associated with cerebral palsied children due to impaired neuromuscular control of the oral, pharyngeal, and respiratory muscles involved in swallowing. It can result in serious complications such as aspiration, malnutrition, dehydration, prolonged feeding time, and recurrent respiratory infections, which in turn may negatively influence the child's nutritional status, growth, and overall quality of life. Several rehabilitation approaches have been developed to improve swallowing function and feeding performance in cerebral palsied children. However, there is little evidence directed toward which intervention procedure is more effective on dysphagia therefore, there is need to compare between the therapeutic effect of kinesiotaping versus neuromuscular electrical stimulation on dysphagia in children with bilateral spastic 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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages will be ranged from 3 to 7 years old.
- •They scored ≤10 on an initial evaluation of Oral Motor Assessment scale.
- •They scored from 5 to 7 in accordance to dysphagia severity scale.
- •Sufficient cognition to follow simple verbal instructions.
排除标准
- •Congenital problems of mouth and soft plate (e.g: cleft lip and plate).
- •Jaw anomalies.
- •Gum and/or dental problems.
- •Chest infection or unstable cardiopulmonary conditions.
- •Uncontrolled seizures.
- •History of recent surgery or trauma affecting the head, neck, or oral region.
- •Skin allergies that prevent the application of kinesio-tape or electrical stimulation electrodes.
结局指标
主要结局
Oral Motor Skills
时间窗: Up to 12 weeks
Oral Motor Assessment Scale will be used to assess oral motor skills. It is a reliable scale consists of seven items compromising oral-motor skills (Mouth closure, Lip closure onto the utensil, lip closure during degluition, control of the food during degluition, straw suction, contol of liquids during degluition, and mastication) that are scored from 0 to 3 (0-passive, 1-sub-functional, 2-semi-functional, and 3-functional).
Swallowing Function
时间窗: Up to 12 weeks
Pediatric Eating Assessment Tool (PEDIEAT-10) will be used to assess swallowing function. It is an eating screener tool include 10-items (gags with smooth food like pudding, insists on being fed by the same person(s), has to be reminded to chew food, shows more stress during meals than during non-meal times (whines, cries, gets angry, tantrums), refuses to eat, is willing to feed self (if younger in age, holds cup, feeds self crackers), throws up during mealtime, arches back during or after meals, gets tired from eating and is not able to finish, and gags when it is time to eat (for example, when they see food or when placed in high chair)) that scored from never to always (never, almost never, sometimes, often, almost always, and always).
次要结局
未报告次要终点
研究者
Eman Wagdy
Assistant Professor
Beni-Suef University