Local Vibration for Drooling in Children With Cerebral Palsy
2026年6月15日 更新者：Merve Tunçdemir、Bitlis Eren University
Effects of Local Vibration on Orofacial Muscle Tone and Drooling in Children With Cerebral Palsy
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ömer DURSUN, Assoc. Prof.
- 电话号码：+90 5426088687
- 邮箱：fztomrdrsn@gmail.com
研究联系人备份
- 姓名：Merve Tunçdemir, Asst. Prof.
- 电话号码：+90 5069452008
- 邮箱：merve.kd@hotmail.com
学习地点
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Van、土耳其（türkiye）
- 招聘中
- Atlas Özel Eğitim ve Rehabilitasyon Merkezi
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接触：
- Merve Tunçdemir Dursun
- 电话号码：+90 507 725 4261
- 邮箱：merve.kd@hotmail.com
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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%
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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Local vibration therapy will be applied to the perioral and submandibular regions using a vibration device for 5 minutes each (total 10 minutes per session), once daily for three consecutive days.
|
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假比较器：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.
|
Sham vibration will be administered using the same device without contact with the skin.
The intervention will be delivered for 10 minutes per session, once daily for three consecutive days.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Muscle Tone
大体时间：Baseline, immediately after the third intervention session, and 1-week follow-up
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Muscle tone of the perioral and submandibular muscles (orbicularis oris and anterior digastric muscles) will be evaluated using a portable hand-held myotonometer (MyotonPRO).
The MyotonPRO applies a short mechanical impulse to the skin overlying the muscle or fascia.
The tissue response generates a signal that is recorded, and the internal software produces an acceleration graph.
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Baseline, immediately after the third intervention session, and 1-week follow-up
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Muscle Stiffness
大体时间：Baseline, immediately after the third intervention session, and 1-week follow-up
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Muscle stiffness of the perioral and submandibular muscles (orbicularis oris and anterior digastric muscles) will be evaluated using a portable hand-held myotonometer (MyotonPRO).
The MyotonPRO applies a short mechanical impulse to the skin overlying the muscle or fascia.
The tissue response generates a signal that is recorded, and the internal software produces an acceleration graph.
|
Baseline, immediately after the third intervention session, and 1-week follow-up
|
|
Muscle Elasticity (logarithmic decrement)
大体时间：Baseline, immediately after the third intervention session, and 1-week follow-up
|
Muscle elasticity of the perioral and submandibular muscles (orbicularis oris and anterior digastric muscles) will be evaluated using a portable hand-held myotonometer (MyotonPRO).
The MyotonPRO applies a short mechanical impulse to the skin overlying the muscle or fascia.
The tissue response generates a signal that is recorded, and the internal software produces an acceleration graph.
|
Baseline, immediately after the third intervention session, and 1-week follow-up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in drooling severity and frequency
大体时间：Baseline, immediately after the third intervention session, and 1-week follow-up
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Drooling severity and frequency will be assessed using a standardized drooling scale, with severity scored from 1 (no drooling) to 5 (severe drooling) and frequency scored from 1 (no drooling) to 4 (constant drooling)
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Baseline, immediately after the third intervention session, and 1-week follow-up
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Global Rating of Change Scale
大体时间：Immediately after the third intervention session and 1-week follow-up
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Parent-reported global rating of change using the Global Rating of Change Scale.
Scores range from -7 (very much worse) to +7 (very much improved), with higher scores indicating greater perceived improvement.
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Immediately after the third intervention session and 1-week follow-up
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Caregiver-reported drooling burden
大体时间：Baseline, immediately after the third intervention session, and 1-week follow-up
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Caregivers will report the frequency of clothing changes and use of tissues related to drooling.
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Baseline, immediately after the third intervention session, and 1-week follow-up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：merve tunçdemir, Asst. Prof.、Bitlis Eren University
- 首席研究员：Ömer DURSUN, Assoc. Prof.、Bitlis Eren University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月15日
初级完成 (估计的)
2026年8月27日
研究完成 (估计的)
2026年8月27日
研究注册日期
首次提交
2026年4月17日
首先提交符合 QC 标准的
2026年6月2日
首次发布 (实际的)
2026年6月4日
研究记录更新
最后更新发布 (实际的)
2026年6月16日
上次提交的符合 QC 标准的更新
2026年6月15日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.