Clinical trial NCT06785220: The Effects of Oral Facial Facilitation and Oral Motor Therapy in Dysphagia
Official title: The Effects of Oral Facial Facilitation and Oral Motor Therapy in Dysphagia with Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysphagia
Spastic Cerebral Palsy (sCP)
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 13
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


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.

Primary outcomes:
measure: functional oral intake scale
timeFrame: through study completion, an average of 6 months
measure: Simplified dysphagia severity rating scale
timeFrame: through study completion, an average of 6 months
measure: Eating Assessment Tool-10
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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