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Not yet recruiting NCT06785220

The Effects of Oral Facial Facilitation and Oral Motor Therapy in Dysphagia

No phase Interventional Dysphagia Spastic Cerebral Palsy (sCP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ORAL FACIAL FACILITATION, ORAL MOTOR THERAPY, ORAL FACIAL FACILITATION WITH ORAL MOROR THERAY.
Who it may be relevant to
Registry conditions: Dysphagia, Spastic Cerebral Palsy (sCP). Basic parameters: 3 years — 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effects of Oral Facial Facilitation and Oral Motor Therapy in Dysphagia with Spastic Cerebral Palsy

Overview

The objective of this research is to investigate the impact of oral facial facilitation and oral motor therapy dysphagia in individuals with spastic cerebral palsy. Specifically, the study aims to: * Evaluate changes in dysphagia and severity following a regimen of oral motor therapy and oral facial facilitation. * Assess improvements in swallowing function, including ease of swallowing and reduction in dysphagia symptoms, after implementing oral motor therapy and oral facial facilitation.

Interventions

  • Other ORAL FACIAL FACILITATION
    A group will receive oral facial facilitation which included exercise for given, 1. Brushing 2. Vibration 3. Manipulation (stroking and tapping) 4. Oral motor sensory exercise (lip, tongue, swallowing exercises)
  • Other ORAL MOTOR THERAPY
    B group will receive oral motor therapy which included exercise for given, 1. A volcano bubbles 2. Party blower target 3. Bubble blowing 4. Curly straws
  • Other ORAL FACIAL FACILITATION WITH ORAL MOROR THERAY
    C group will receive oral facial facilitation and oral motor therapy which included exercise for given, 1. Brushing 2. Vibration 3. Manipulation (stroking and tapping) 4. Oral motor sensory exercise (lip, tongue, swallowing exercises) 5. A volcano bubbles 6. Party blower target 7. Bubble blowing 8. Curly straws

Primary outcome measures

  • functional oral intake scale [Time frame: through study completion, an average of 6 months]
  • Simplified dysphagia severity rating scale [Time frame: through study completion, an average of 6 months]
  • Eating Assessment Tool-10 [Time frame: through study completion, an average of 6 months]

Eligibility criteria

Inclusion criteria

  • 1\. Confirmed diagnosis of spastic cerebral palsy (CP) by a qualified medical professional.

2\. Participants aged 3 to 7 years, as this is a common demographic affected by spastic CP.

3\. Clinical diagnosis of dysphagia, confirmed by a speech-language pathologist or related healthcare provider.

4\. No recent significant changes in neurological status or medical condition within the last six months.

5\. Sufficient cognitive ability to follow simple instructions during therapy sessions, as assessed by a qualified professional.

6\. Parental or guardian consent obtained for participants under 18, along with assent from participants when appropriate.

7\. No recent (within the last three months) oral motor therapy interventions that could confound results.

8\. Willingness and ability of the participant to engage in therapy sessions consistently.

9\. Clearance from a physician to participate in oral motor therapy and related interventions.

Exclusion criteria

  • 1\. Diagnosis of other neurological disorders or conditions that may affect swallowing or motor skills.

2\. Serious medical conditions or comorbidities that could interfere with therapy (e.g., severe respiratory issues).

3\. Any surgical interventions affecting the oral or pharyngeal region within the last year.

4\. Concurrent participation in other clinical trials or interventions that could affect swallowing outcomes.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Furkim AM, Behlau MS, Weckx LLM. The use of cervical auscultation in tracheal aspiration in children with cerebral palsy. Rev. CEFAC. 2009;11(4):624-9.
  • IOSR Journal of Dental and Medical Sciences (IOSR-JDMS) e-ISSN: 2279-0853, p-ISSN: 2279-0861.Volume 14, Issue 8 Ver. VI (Aug. 2015), PP 09-13
  • Kumari P., Nikkitha E. To compare the effects of oral facial facilitation and oral motor therapy in decreasing drooling in children with spastic cerebral palsy. Int. J. Pharm. Biol. Sci. 2018;8:397-402.
  • Ottenbacher K, Scoggins A, Wayland J. The effectiveness of a program of oral sensory-motor therapy with the severely and profoundly developmentally disabled. Occup Ther J Res 1981; 1: 147-60
  • Walton K, Daniel AI, Mahood Q, Vaz S, Law N, Unger SL, O'Connor DL. Eating Behaviors, Caregiver Feeding Interactions, and Dietary Patterns of Children Born Preterm: A Systematic Review and Meta-Analysis. Adv Nutr. 2022 Jun 1;13(3):875-912. doi: 10.1093/advances/nmac017. PMID 35157009
  • Simons A, Hamdy S. The Use of Brain Stimulation in Dysphagia Management. Dysphagia. 2017 Apr;32(2):209-215. doi: 10.1007/s00455-017-9789-z. Epub 2017 Mar 28. PMID 28353151
  • Sigan SN, Uzunhan TA, Aydinli N, Eraslan E, Ekici B, Caliskan M. Effects of oral motor therapy in children with cerebral palsy. Ann Indian Acad Neurol. 2013 Jul;16(3):342-6. doi: 10.4103/0972-2327.116923. PMID 24101813
  • Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. PMID 17370477

Identifiers

NCT: NCT06785220 · OMT and OFF in Dysphagia

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗