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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local Vibration Group | Experimental | 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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| Sham Vibration Group | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local Vibration Therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Tone | 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. | Baseline, immediately after the third intervention session, and 1-week follow-up |
| Muscle Stiffness | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in drooling severity and frequency | 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) | Baseline, immediately after the third intervention session, and 1-week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Merve Tunçdemir, Asst. Prof. | Contact | 5069452008 | +90 | merve.kd@hotmail.com |
| Ömer Dursun, Assoc. Prof. | Contact | 5426088687 | +90 | fztomrdrsn@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Merve Tunçdemir, Asst. Prof. | Bitlis Eren University | Principal Investigator |
| Ömer Dursun, Assoc. Prof. | Bitlis Eren University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlas Özel Eğitim ve Rehabilitasyon Merkezi | Recruiting | Van | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D012798 | Sialorrhea |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Sham Vibration | Other | 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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| Global Rating of Change Scale |
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. |
| Immediately after the third intervention session and 1-week follow-up |
| Caregiver-reported drooling burden | Caregivers will report the frequency of clothing changes and use of tissues related to drooling. | Baseline, immediately after the third intervention session, and 1-week follow-up |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |