Effect of Masticatory Electrical Stimulation on Dysphagia in Spastic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- feeding level progress
研究概览
简要总结
This study was conducted to evaluate the effectiveness of masticatory muscles electrical stimulation on oromotor skills, feeding level progress and child growth in children with dyaphagia. Forty children diagnosed as spastic cerebral palsy, from both genders, age ranging from 2 to 5 years were enrolled in the current study. They were randomly allocated in to study group (A) received oromotor exercises and neuromuscular electrical stimulation on masseter and digastric muscles and control group (B) received same exercises but placebo electrical stimulation. The result showed significant improvement in all variables in both groups. However, the study group showed significant different in feeding level in compare with control group.
详细描述
Study design:
A randomized controlled clinical trial was conducted after interviews were done with the parents or care givers of all children, before starting the study to demonstrate the aim, procedures and potential benefits of the study. Children' parents provided written informed consent before the study was conducted.
Participants:
Forty spastic CP children (26 girls and 14 boys), age ranging from 2 to 5 years, participated in this study. They were selected based on the following criteria; having at least score (level 4) according to functional oral intake scale (FOIS), and they had good head control. Children were excluded if they had; oral hypersensitivity, acute or chronic dental problems, released primitive reflexes as asymmetrical tonic neck reflex or Seizures.
Participants who met the eligible criteria were assigned randomly to either study or control group of equal numbers. Each child in both groups received an oro-motor exercises program as home routine 3 times daily before each meal. Children in the study group received 20-minutes of neuromuscular electrical stimulation (NMES) (multi current SND 64227) which consisted of two-channels electrotherapy system designed for neuromuscular rehabilitation. The NMES was applied with 60 Hz of 230 milliseconds twice weekly for 8 weeks. While participants in the control group received placebo NMES.
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
participants did not have knowldge if they in study or in control group ,as the exercises applied the same in both group and electrical stimulation the same ,the device turn on in both groups but their is no real signals reached to control group.
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of spastic cerebral palsy.
- •age ranged from 2 to 5 years.
- •They had score level 4 or more according to functional oral intake scale (FOIS)
- •They had head control
排除标准
- •oral hypersensitivity.
- •any acute or chronic dental problems
- •released primitive reflexes as asymmetrical tonic neck reflex.
- •genetic syndrome
研究组 & 干预措施
Effect of electrical stimulation on dysphagia in cp
the study group that was treated by selected oromotor exercise program in addition to neuromuscular electrical stimulation, Feeding level progress was evaluated by functional oral intake scale,oro motor skills were evaluate by oromotor assessment scale, weight gain and height were measured pre and post 2 months of the treatment.
干预措施: oromotor exercises and neuromuscular electrical stimulations (Other)
effect of oromotor exercise on dysphagia in cp
the control group was treated by the same oromotor exercise program in addition to placebo effect of neuromuscular electrical stimulation. Feeding level progress was evaluated by functional oral intake scale,oro motor skills were evaluate by oromotor assessment scale, weight gain and height were measured pre and post 2 months of the treatment.
干预措施: oromotor exercises and neuromuscular electrical stimulations (Other)
结局指标
主要结局
feeding level progress
时间窗: time of treatment was two months
functional feeding level evaluated with functional oral intake scale .this scale contain one item (feeding level) .the score ranging from level one to level seven seven levels ,the best level is level seven ( total oral intake without restrictions) the worth level is level one 9tube dependent .the final score is the number of level .assessed pre and post treatment
oromotor skills
时间窗: period of treatment was two months
oro motor assessment scale assess oromotor skills , it has seven items each item has four scores from zero to three, zero the worth and three the best. Each item was assessed 30 s. Their was no interfering with the way the caregiver or the child ingested the food, When the child presented more than one type of oral motor skill for the same item, the most frequently used skill was considered during the assessment. The final classification score of oral motor skill was attributed based on the most frequent score and if there was a tie between two scores, the highest score determined the diagnosis of the predominant type oro motor skills assessed pre and post ttt
weight gain
时间窗: period of treatment was two months
assess weight pre and post ttt by weight measuring scale.Child who able to stand was asked to stand on the weight measuring scale and record the weight of the child as show in The child who unable to stand assess weight of mother while carrying the child and record the weight then assess weight of mother alone and record her weight also ,then substract to find the weight of child in kg
height
时间窗: period of treatment was two months
assess height pre and post ttt by height measuring scale.Child who able to stand was asked to stand on the height measuring scale and elevate the arm of the height measuring scale till the vertex of the child then the height was recorded. child who unable to stand ask mother to lie the child supine line position then take land mark from the far point of the head , then take also land mark from the most far point from the heel and keep knee extended, after that measure the distance between two land mark and record the height in cm .
次要结局
未报告次要终点
研究者
amira farag
Principal Investigator
Cairo University