DysphagiaNCT06785220

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

A study testing ORAL FACIAL FACILITATION, ORAL MOTOR THERAPY and ORAL FACIAL FACILITATION WITH ORAL MOROR THERAY in people with Dysphagia and Spastic Cerebral Palsy (sCP), run by Kafrelsheikh University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 3 to 7 years
Conditions the study is for: Dysphagia, Spastic Cerebral Palsy (sCP)
What is being tested?: ORAL FACIAL FACILITATION, ORAL MOTOR THERAPY and ORAL FACIAL FACILITATION WITH ORAL MOROR THERAY
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: No sites listed yet
Study dates: 1 Feb 2025to 30 Aug 2025
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 7 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Show all 9Show fewer

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.

Who cannot join

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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Marwa Abd Elmawgood Abdo Ragab, BSc. contact

+201018466190

m.elshafie15@gmail.com

About this study

Official title: 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.

Conditions: Dysphagia, Spastic Cerebral Palsy (sCP)
Being tested: ORAL FACIAL FACILITATION, ORAL MOTOR THERAPY, ORAL FACIAL FACILITATION WITH ORAL MOROR THERAY
Medical subject headings: Deglutition Disorders, Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ORAL FACIAL FACILITATIONOther
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)
ORAL MOTOR THERAPYOther
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
ORAL FACIAL FACILITATION WITH ORAL MOROR THERAYOther
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

Study groups in NCT06785220
Study group	Role	What they receive
Group A: ORAL FACIAL FACILITATION	Active comparator	•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) Receives: Other: ORAL FACIAL FACILITATION
Group B: ORAL MOTOR THERAPY	Active comparator	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 Receives: Other: ORAL MOTOR THERAPY
Group C: ORAL FACIAL FACILITATION WITH ORAL MOROR THERAY	Active comparator	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 Receives: Other: ORAL FACIAL FACILITATION WITH ORAL MOROR THERAY

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202530 Aug 2025

First posted21 Jan 2025
Study start1 Feb 2025 (estimated)
Primary completion30 Jul 2025 (estimated)
Study completion30 Aug 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (33)Papers the sponsor has linked to this study.
Other trials for DysphagiaStudies of the same condition, open and under way.
More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 13 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06785220
Sponsor's protocol ID: OMT and OFF in Dysphagia
Status last verified: Jan 2025
First submitted: 6 Jan 2025
Last updated: 21 Jan 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 17370477
Reilly S, Skuse D. Characteristics and management of feeding problems of young children with cerebral palsy. Dev Med Child Neurol. 1992 May;34(5):379-88. doi: 10.1111/j.1469-8749.1992.tb11449.x.
PubMed 1592191
Rangarathnam B, Kamarunas E, McCullough GH. Role of cerebellum in deglutition and deglutition disorders. Cerebellum. 2014 Dec;13(6):767-76. doi: 10.1007/s12311-014-0584-1.
PubMed 25047686
Pearson WG Jr, Langmore SE, Zumwalt AC. Evaluating the structural properties of suprahyoid muscles and their potential for moving the hyoid. Dysphagia. 2011 Dec;26(4):345-51. doi: 10.1007/s00455-010-9315-z. Epub 2010 Nov 11.
PubMed 21069388
Parkes J, Hill N, Platt MJ, Donnelly C. Oromotor dysfunction and communication impairments in children with cerebral palsy: a register study. Dev Med Child Neurol. 2010 Dec;52(12):1113-9. doi: 10.1111/j.1469-8749.2010.03765.x. Epub 2010 Aug 31.
PubMed 20813020
Park JS, Hwang NK, Kim HH, Choi JB, Chang MY, Jung YJ. Effects of lingual strength training on oropharyngeal muscles in South Korean adults. J Oral Rehabil. 2019 Nov;46(11):1036-1041. doi: 10.1111/joor.12835. Epub 2019 Jul 2.
PubMed 31206763
Pakula AT, Van Naarden Braun K, Yeargin-Allsopp M. Cerebral palsy: classification and epidemiology. Phys Med Rehabil Clin N Am. 2009 Aug;20(3):425-52. doi: 10.1016/j.pmr.2009.06.001.
PubMed 19643346
Min KC, Seo SM, Woo HS. Oral-motor facilitation technique (OMFT): Part I-Theoretical Base and Basic Concept. Therapeutic Sci Rehabilitation. 2021;10(1):37-52. https://doi.org/10.22683/tsnr.2021.10.1.037

Interested in taking part?

Marwa Abd Elmawgood Abdo Ragab, BSc.

+201018466190

m.elshafie15@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Dysphagia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Oral Facial Facilitation and Oral Motor Therapy in Dysphagia with Spastic Cerebral Palsy
ClinicalTrials.gov ID: NCT06785220
Acronym / sponsor ID: OMT and OFF in Dysphagia
Conditions: Dysphagia, Spastic Cerebral Palsy (sCP)
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 13 participants (estimated)
Lead sponsor: Kafrelsheikh UniversityUniversity, hospital or other
Study start: 1 Feb 2025 (estimated)
Primary completion: 30 Jul 2025 (estimated)
Study completion: 30 Aug 2025 (estimated)
First posted: 21 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A: ORAL FACIAL FACILITATION	Active comparator	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)
Group B: ORAL MOTOR THERAPY	Active comparator	Other: ORAL MOTOR THERAPYB 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
Group C: ORAL FACIAL FACILITATION WITH ORAL MOROR THERAY	Active comparator	Other: ORAL FACIAL FACILITATION WITH ORAL MOROR THERAYC 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

Who may qualify

Ages: 3 to 7 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ORAL FACIAL FACILITATIONA 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	Group A: ORAL FACIAL FACILITATION
ORAL MOTOR THERAPYB 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	Group B: ORAL MOTOR THERAPY
ORAL FACIAL FACILITATION WITH ORAL MOROR THERAYC 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	Group C: ORAL FACIAL FACILITATION WITH ORAL MOROR THERAY

Primary outcome

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
BackgroundFurkim 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.
BackgroundIOSR 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
BackgroundKumari 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.
BackgroundOttenbacher 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
Background: PubMed 35157009Walton 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.
Background: PubMed 28353151Simons 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.
Background: PubMed 24101813Sigan 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.
Background: PubMed 17370477Rosenbaum 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.
Background: PubMed 1592191Reilly S, Skuse D. Characteristics and management of feeding problems of young children with cerebral palsy. Dev Med Child Neurol. 1992 May;34(5):379-88. doi: 10.1111/j.1469-8749.1992.tb11449.x.
Background: PubMed 25047686Rangarathnam B, Kamarunas E, McCullough GH. Role of cerebellum in deglutition and deglutition disorders. Cerebellum. 2014 Dec;13(6):767-76. doi: 10.1007/s12311-014-0584-1.
Background: PubMed 21069388Pearson WG Jr, Langmore SE, Zumwalt AC. Evaluating the structural properties of suprahyoid muscles and their potential for moving the hyoid. Dysphagia. 2011 Dec;26(4):345-51. doi: 10.1007/s00455-010-9315-z. Epub 2010 Nov 11.
Background: PubMed 20813020Parkes J, Hill N, Platt MJ, Donnelly C. Oromotor dysfunction and communication impairments in children with cerebral palsy: a register study. Dev Med Child Neurol. 2010 Dec;52(12):1113-9. doi: 10.1111/j.1469-8749.2010.03765.x. Epub 2010 Aug 31.
Individual participant dataSharing planned: Undecided

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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Marwa Abd Elmawgood Abdo Ragab, BSc. contact

+201018466190

m.elshafie15@gmail.com

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marwa Abd Elmawgood Abdo Ragab, BSc. (+201018466190, m.elshafie15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

functional oral intake scale (time frame: through study completion, an average of 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06785220, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2025.