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临床试验/CTRI/2023/06/053670
CTRI/2023/06/053670尚未招募2 期

Development & Evaluation of Neuromuscular Electrical Stimulation & Vibrator Device in Improvement of Feeding and Swallowing and Reduction in Drooling among Cerebral Palsy children.

Dr Deepa Gurunathan1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年1月7日最近更新:

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)

研究者

发起方
Dr Deepa Gurunathan
申办方类型
Other [Self funded]

研究点 (1)

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