Effects of Local Vibration on Orofacial Muscle Tone and Drooling in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
This randomized-controlled trial evaluates local vibration therapy for drooling and orofacial muscle biomechanics in children with cerebral palsy. Participants receive either local vibration plus conventional physiotherapy or sham vibration plus conventional physiotherapy.
详细描述
This randomized-controlled trial aims to evaluate the effects of local vibration therapy on drooling severity and perioral and submandibular muscle biomechanics in children with cerebral palsy. Participants will be allocated to either an experimental group receiving local vibration in addition to conventional physiotherapy or a control group receiving sham vibration with conventional physiotherapy. Local vibration will be applied to the perioral and submandibular regions for 5 minutes each over three consecutive days. Assessments will be conducted at baseline, immediately after the third intervention session, and at 1-week follow-up.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cerebral palsy
- •Age between 2 and 18 years
- •Presence of anterior drooling
- •Drooling severity and frequency score ≥ 3 on a standardized drooling scale
排除标准
- •History of surgical intervention for drooling management
- •History of botulinum toxin injection for drooling management
- •Use of medications affecting salivary control
- •Presence of progressive neurological disease
- •Presence of salivary gland pathology or active upper respiratory tract infection
- •History or symptoms of aspiration pneumonia within the last 6 months
- •Indication for surgical treatment of drooling (e.g., more than four clothing changes per day and presence of chin or neck dermatitis)
- •Uncontrolled seizures
- •Presence of oral or perioral lesions
- •Presence of gastrostomy tube
- •Treatment adherence below 85%
研究组 & 干预措施
Local Vibration Group
In this group, participants will receive conventional physiotherapy combined with local vibration therapy. Local vibration will be applied to the perioral and submandibular regions for 5 minutes each (total 10 minutes per session) once daily for three consecutive days using a vibration device.
干预措施: Local Vibration Therapy (Other)
Sham Vibration Group
In this group, participants will receive conventional physiotherapy combined with sham vibration. The vibration device will be activated but not applied to the skin surface. The procedure will mimic the experimental protocol in duration and setting and will be performed once daily for three consecutive days.
干预措施: Sham Vibration (Other)
研究者
Merve Tunçdemir
Assistant Professor
Bitlis Eren University