The Effect of Home-Based Action Observation Training on Chewing and Swallowing Function in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Behavioral Pediatrics Feeding Assessment Scale
研究概览
简要总结
This study is a two-part randomized controlled trial designed to investigate the effects of home-based Action Observation Training (AOT) combined with Functional Chewing Training (FuCT) in children with Cerebral Palsy (CP) who have chewing disorders.
In Part I, the primary outcome results-chewing function, swallowing function, and feeding behaviour-will be reported. In Part II, the secondary outcome results, including child participation, quality of life, and caregiver impact, will be presented.
Within the scope of the study, children with CP will be randomly allocated to either a study group or a control group. Both groups will receive FuCT (5 sets per day, 5 days per week, for 12 weeks). In addition, the study group will participate in a home-based AOT program delivered via telerehabilitation (1 set per day, 3 days per week, for 12 weeks) under the guidance of a physiotherapist.
All participants will be assessed at baseline, at week 6, and at the end of week 12.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Cerebral Palsy,
- •Age between 6 and 18,
- •IQ level of 70 or above,
- •Having complaints related to chewing function and inability to manage solid food intake
- •Feeding orally.
排除标准
- •Having a neurodegenerative disease other than Cerebral Palsy
- •Having additional chronic illnesses such as systemic diseases, cancer, kidney diseases, gastrointestinal system diseases, etc., that may affect nutritional status,
- •Experiencing visual or hearing impairment,
- •Using any medication and/or oral device that may affect chewing performance,
- •Having received previous chewing and/or swallowing training.
研究组 & 干预措施
Study Group
干预措施: Functional Chewing Exercise (Other)
Study Group
干预措施: Action Observation Training (Other)
Control Group
干预措施: Functional Chewing Exercise (Other)
结局指标
主要结局
Behavioral Pediatrics Feeding Assessment Scale
时间窗: Up to 12 Weeks
It is used in the assessment of child feeding behavior. The scale is a 35-question questionnaire that has been culturally adapted and its Turkish validity and reliability have been demonstrated.
Karaduman Chewing Performance Scale
时间窗: Up to 12 Weeks
The Karaduman Chewing Performance Scale is an ordinal scale that is valid, reliable, quick and clinically easy to use to determine the chewing performance level in children with cerebral palsy.
Turkish version of the Mastication Observation and Evaluation Instrument
时间窗: Up to 12 Weeks
It is used to evaluate chewing skills.It is a criterion-referenced instrument used to assess individual masticatory skills necessary for efficient intake of solid foods.
Test of Masticating and Swallowing Solids in Children
时间窗: Up to 12 Weeks
It is used to quantitatively evaluate the effectiveness of chewing function.This is a norm-referenced, valid and reliable tool for quantitatively assessing the efficiency of masticatory function in children aged 4-18 years.
Dysphagia Disorder Survey (DDS) and Dysphagia Management Staging Scale (DMSS)
时间窗: Up to 12 Weeks
DDS is used to evaluate swallowing function. It is a valid and reliable swallowing disorder assessment tool developed and standardised in child and adult populations diagnosed with intellectual and developmental disabilities. It is based on video-recording and observation of a typical meal in which the child consumes foods appropriate to his/her diet. DMSS is an ordinal scale that classifiesused to classify the severity of dysphagia into five levels based on the DDS score.
次要结局
- Pediatric Evaluation of Disability Inventory(Up to 12 Weeks)
- Pediatric Quality of Life Inventory Cerebral Palsy Module (PedsQL CP Module)(Up to 12 weeks)
- Turkish version of the Feeding/Swallowing Impact Survey (T-FS-IS)(Up to 12 week)
研究者
Seda Nur Kemer
PT, PhD, Academic Lecturer
Ondokuz Mayıs University