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临床试验/CTRI/2024/07/071235
CTRI/2024/07/071235已完成不适用

EFFECT OF GLOBAL INTENSIVE FEEDING THERAPY (GIFT) ON FEEDING AND MEALTIME BEHAVIOUR IN CHILDREN WITH CEREBRAL PALSY- A Randomized Controlled Trial

Shreya Bavi1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年8月4日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
1.Oral Motor Assessment Scale(OMAS)

研究概览

简要总结

Many children with cerebral palsy experience and struggle with feeding problems, which can lead to issues like poor growth, difficulty eating and frequent respiratory illnesses. These challenges are often due to sensory and motor issues which can make the mealtime frustrating for both the child and their family. Behavioural issues such as food refusal, gagging, and vomiting are common. Commonly used treatment for these children are the oromotor exercises but, they have limited scientific proof of effectiveness. A new program called GIFT (Global Intensive Feeding Therapy) will help in improving feeding skills in these children, and this study will assess its impact on feeding and mealtime behaviour.The children will be recruited and study will be explained to the parents.Demographic data will be recorded and pre-treatment assessment of feeding and mealtime behaviour will be done. Children in the Experimental group will be undergoing intensive rehabilitation i.e Global Intensive Feeding Therapy (GIFT). The intensive training will be performed by the therapist. Parents will be trained with specific techniques to use at home to help your child to generalize feeding abilities and mealtime behaviour during the first session. Control group will be undergoing Conventional oromotor exercises. Both the groups will be receiving the treatment 3times/day for 5 days in a week for 2 consecutive weeks. Outcome measures will be evaluated after the two-week treatment period and results will be calculated.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
1.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • 1.All gender children diagnosed with CP aged between 1-10 years 2.Score of 0-2 on initial assessment of OMAS 3.Children fed orally 4.Age of mother more than 19 years, able to comprehend and follow intervention/instruction in vernacular language.

排除标准

  • Children with cleft lip and palate; gum infections and congenital problems of mouth and soft palate
  • Children with uncontrolled seizures
  • Children diagnosed with any metabolic, cardiopulmonary, gastrointestinal disorders and other neurological impairments
  • Caregivers unable to comply with research procedures and hospital visit after 2 weeks.

结局指标

主要结局

1.Oral Motor Assessment Scale(OMAS)

时间窗: T1- baseline | T2- post-intervention(after 2 weeks)

2.Behavioural Pediatrics Feeding Assessment Scale(BPFAS)

时间窗: T1- baseline | T2- post-intervention(after 2 weeks)

次要结局

未报告次要终点

研究者

发起方
Shreya Bavi
申办方类型
Other [self-sponsored]
责任方
Principal Investigator
主要研究者

SHREYA MALLIKARJUN BAVI

KAHER Institute of Physiotherapy, Belgaum

研究点 (1)

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