Development & Evaluation of Neuromuscular Electrical Stimulation & Vibrator Device in Improvement of Feeding and Swallowing and Reduction in Drooling among Cerebral Palsy children.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- tone,strength & coordination of oro facial muscles
研究概览
简要总结
Cerebral palsy (CP) is the commonest neurodevelopmental disorder of childhood because of a non-progressive damage to the brain, which leads to various activity limitations caused by progressive postural and movement disturbances. Globally it is reported that the prevalence range of CP is from 1.5 to 4 per 1000 live births , however the prevalence range reported for India is higher ranging from 2.08 to 3.88 per 1000 live births.Parents and families of CP children experience an higher levels of stress and depression and, have a lower quality of life as compared to parents of healthy children. In addition ,CP also affects oral motor skills, leading to speech delay, drooling and difficulties with sucking, swallowing, and chewing.Inability to chew leads to retarded growth and development, while drooling becomes a major hindrance in social development. Children with CP also encounter dental caries, dental trauma, malocclusion, and compromised periodontal status due to their insufficient neuromuscular activity.Due to reduced neuromuscular control an higher incidence of sleep disorder breathing including obstructive sleep apnea is observed in children with Cerebral Palsy
Aims & objective with reason
Reason: Sensory application such as electric stimulation and high frequency vibrations have shown to improve the strength of oral and masticatory muscles aiding in reduction of drooling and improving swallowing and chewing.The need of the hour is for a device that is economical and which be used diligently by parents at home. Therefore this instrument will have an beneficial effect on functional independence level and improving the quality of life of children with Cerebral Palsy.
Aim:
To develop an unique indigenous device that gives electrical stimulation and vibration that will enhance the strength,coordination and activity of oro facial muscles in CP children.
To compare the improvement in the tone, strength, coordination and activity of oro facial muscles with the existing professional equipment that is used for management of CP children
Objective
To develop a device to improve the tone, strength,coordination and activity of oro facial muscles among children with CP.
To use the instrument in children with CP aged 3 to 6 year and evaluate the improvement in the tone, strength,coordination using surface electromyography and activity of oro facial muscles.
To evaluate the improvement in the tone, strength,coordination using surface electromyography and activity of oro facial muscles with the existing professional equipment in children with CP aged 3 to 6 year
To compare the effect of the newly developed device and existing one on the the tone, strength,coordination and activity of oro facial muscles and oral motor functions of CP children
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 6.00 Year(s)(—)
- 性别
- All
入选标准
- • Score below 10 in baseline The Oral Motor Assessment Scale (OMAS) Willingness of participation of parents in more than 80% of the whole process Have no experience of Stimulation therapy Children without head and neck control problems Children with no audible, visible perceptual deficiency.
排除标准
- •Children with history of seizures.
- •Children on tube feeding and have a history of aspiration.Â.
结局指标
主要结局
tone,strength & coordination of oro facial muscles
时间窗: pre treatment & post treatment
次要结局
- activity of orofacial muscles(pre treatment & post treatment)
