Comparison of the Effects of Orofacial Therapy and Therapeutic Yoga on Swallowing, Sleeping Habits and Quality of Life in Children With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The Pediatric Functional Independence Measure
研究概览
简要总结
The study aims to compare the effects of orofacial therapy and therapeutic yoga on swallowing, sleep habits, and quality of life in children with Down syndrome.
详细描述
At special education and rehabilitation centers, children diagnosed with Down syndrome will undergo initial assessment, and those meeting the inclusion criteria will be included in the study following parental voluntary consent.
Measurement assessments will be conducted three times: before therapy, after therapy (at week 8), and at a follow-up at week 12. To ensure a fair and unbiased distribution, children participating in the study will be randomly assigned to their respective groups using a sealed envelope method, a widely accepted and transparent randomization technique.
- Grup: Routine Physiotherapy (PT) Group - Receiving routine physiotherapy treatment.
Children who receive routine physiotherapy treatment in special education centers will be evaluated at the end of the 8th session following the treatment. After 12 weeks, the control will be in the form of an evaluation. 2. Grup: Orofacial Therapy + Routine PT Group - Receiving orofacial therapy and routine physiotherapy treatment.
For the orofacial therapy, sessions will be held twice a week for eight weeks, with each session lasting 30-45 minutes, totaling 16 sessions. This structured and intensive therapy schedule is designed to provide a comprehensive evaluation of the therapy's effectiveness. Secondary evaluations will be conducted following the 8th treatment session, and a follow-up evaluation will be performed after 12 weeks. 3. Grup: Therapeutic Yoga Group + Routine PT Group - Receiving therapeutic yoga and routine physiotherapy treatments.
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)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Down syndrome
- •Age between 5 and 12 years old
- •Scoring 4 or higher on the pEAT-10 questionnaire
- •Obtained parental consent form
- •Ability of the child to cooperate
排除标准
- •Conditions that would impede assessment or communication (such as cognitive problems, psychiatric issues, etc.).
- •Children who have undergone any surgery related to orofacial structures and/or received orthodontic treatment.
- •Those with a history of trauma (whiplash injury, condylar trauma, fractures).
- •Children who have received orofacial-related physical therapy treatment within less than 6 months.
结局指标
主要结局
The Pediatric Functional Independence Measure
时间窗: Baseline, 8 weeks,12 weeks
The Pediatric Functional Independence Measure (WeeFIM): The WeeFIM consists of 18 items across 6 separate domains. These domains include self-care, sphincter control, transfers, mobility, communication, and social-cognitive evaluations. When answering the items in the WeeFIM sections, scoring is based on whether assistance is needed during the activity, and whether any assistive devices are required. The WeeFIM scale yields scores ranging from a minimum of 18 to a maximum of 126 points.
Children's Sleep Habits Questionnaire
时间窗: Baseline, 8 weeks,12 weeks
The Children's Sleep Habits Questionnaire (CSHQ) form contains 33 items, including 8 subscales. The CSHQ assesses the following subscales: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night waking, parasomnias, sleep-disordered breathing, and daytime sleepiness. The scale is filled out retrospectively by parents. A total score of 41 points is considered the cutoff point for the CSHQ, and scores above this threshold indicate that children are experiencing clinically significant sleep problems.
Pediatric Eating Assessment Tool-10
时间窗: Baseline, 8 weeks, 12 weeks
The Pediatric Eating Assessment Tool-10 (p-EAT-10) is a scale consisting of 10 items used to screen the severity of dysphagia symptoms. Each item is scored from 0 to 4 (0=No problem and 4=Severe Problem). Normative data indicate that a p-EAT-10 score of 4 or higher indicates a risk of swallowing disorder, with higher scores indicating more severe dysphagia symptoms.
The Health-Related Quality of Life Scale-KIDSCREEN-27
时间窗: Baseline, 8 weeks,12 weeks
The Health-Related Quality of Life Scale-KIDSCREEN-27 form is drawn from the KIDSCREEN-52 and consists of 27 questions and 5 dimensions. The dimensions of KIDSCREEN-27 include physical well-being (5 items), psychological well-being (7 items), autonomy and relationships with parents (7 items), social support and peers (4 items), and school environment (4 items). In all KIDSCREEN questionnaires, items have a 5-point Likert-type response scale (never, seldom, sometimes, often, always). An increase in score indicates a better quality of life.
次要结局
未报告次要终点
研究者
YASEMİN KOTEVOĞLU
Principal Investigator
Hasan Kalyoncu University