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

January 17, 2025 updated by: Marwa Abd El-Mawgood Abdo Ragab, Kafrelsheikh University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: 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 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)
Active Comparator: Group B: 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 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
Active Comparator: Group C: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
functional oral intake scale
Time Frame: through study completion, an average of 6 months
through study completion, an average of 6 months
Simplified dysphagia severity rating scale
Time Frame: through study completion, an average of 6 months
through study completion, an average of 6 months
Eating Assessment Tool-10
Time Frame: through study completion, an average of 6 months
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 17, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMT and OFF in Dysphagia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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