NCT06785220

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

January 21, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 6, 2025

Last Update Submit

January 17, 2025

Conditions

DysphagiaSpastic Cerebral Palsy (sCP)

Outcome Measures

Primary Outcomes (3)

  • functional oral intake scale

    through study completion, an average of 6 months

  • Simplified dysphagia severity rating scale

    through study completion, an average of 6 months

  • Eating Assessment Tool-10

    through study completion, an average of 6 months

Study Arms (3)

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)

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

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

Other: ORAL FACIAL FACILITATION WITH ORAL MOROR THERAY

Interventions

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)

Group A: ORAL FACIAL FACILITATION
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

Group B: ORAL MOTOR THERAPY
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

Group C: ORAL FACIAL FACILITATION WITH ORAL MOROR THERAY

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \. Confirmed diagnosis of spastic cerebral palsy (CP) by a qualified medical professional.
  • \. Participants aged 3 to 7 years, as this is a common demographic affected by spastic CP.
  • \. Clinical diagnosis of dysphagia, confirmed by a speech-language pathologist or related healthcare provider.
  • \. No recent significant changes in neurological status or medical condition within the last six months.
  • \. Sufficient cognitive ability to follow simple instructions during therapy sessions, as assessed by a qualified professional.
  • \. Parental or guardian consent obtained for participants under 18, along with assent from participants when appropriate.
  • \. No recent (within the last three months) oral motor therapy interventions that could confound results.
  • \. Willingness and ability of the participant to engage in therapy sessions consistently.
  • \. Clearance from a physician to participate in oral motor therapy and related interventions.

You may not qualify if:

  • \. Diagnosis of other neurological disorders or conditions that may affect swallowing or motor skills.
  • \. Serious medical conditions or comorbidities that could interfere with therapy (e.g., severe respiratory issues).
  • \. Any surgical interventions affecting the oral or pharyngeal region within the last year.
  • \. Concurrent participation in other clinical trials or interventions that could affect swallowing outcomes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (33)

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

  • 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: 35157009BACKGROUND

  • 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: 28353151BACKGROUND

  • 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: 24101813BACKGROUND

  • 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: 17370477BACKGROUND

  • 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.

    PMID: 1592191BACKGROUND

  • 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.

    PMID: 25047686BACKGROUND

  • 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.

    PMID: 21069388BACKGROUND

  • 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.

    PMID: 20813020BACKGROUND

  • 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.

    PMID: 31206763BACKGROUND

  • 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.

    PMID: 19643346BACKGROUND

  • 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

    BACKGROUND

  • Min KC, Seo SM, Woo HS. Oral-motor facilitation technique (OMFT): Part II-Conceptual Hierarchy and Key Point Technique. Therapeutic Sci Rehabilitation. 2021;10(1):53-61. https://doi.org/10.22683/tsnr.2021.10.1.053.

    BACKGROUND

  • Makris T, Dorstyn D, Crettenden A. Quality of life in children and adolescents with cerebral palsy: a systematic review with meta-analysis. Disabil Rehabil. 2021 Feb;43(3):299-308. doi: 10.1080/09638288.2019.1623852. Epub 2019 Jun 10.

    PMID: 31180733BACKGROUND

  • Li XL, Liu Y, Liu M, Yang CY, Yang QZ. Early Premature Infant Oral Motor Intervention Improved Oral Feeding and Prognosis by Promoting Neurodevelopment. Am J Perinatol. 2020 May;37(6):626-632. doi: 10.1055/s-0039-1685448. Epub 2019 Apr 23.

    PMID: 31013539BACKGROUND

  • Engle RP, Canner GC. Proprioceptive Neuromuscular Facilitation (PNF) and Modified Procedures for Anterior Cruciate Ligament (ACL) Instability. J Orthop Sports Phys Ther. 1989;11(6):230-6. doi: 10.2519/jospt.1989.11.6.230.

    PMID: 18796905BACKGROUND

  • Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82.

    PMID: 27188686BACKGROUND

  • Gisel EG. Oral-motor skills following sensorimotor intervention in the moderately eating-impaired child with cerebral palsy. Dysphagia. 1994 Summer;9(3):180-92. doi: 10.1007/BF00341263.

    PMID: 8082327BACKGROUND

  • Chaleat-Valayer E, Porte M, Buchet-Poyau K, Roumenoff-Turcant F, D'Anjou MC, Boulay C, Bernard JC, Touzet S. Management of drooling in children with cerebral palsy: A French survey. Eur J Paediatr Neurol. 2016 Jul;20(4):524-31. doi: 10.1016/j.ejpn.2016.04.010. Epub 2016 Apr 22.

    PMID: 27155820BACKGROUND

  • Owen SE, Stern ML. Management of drooling in cerebral palsy: three single case studies. Int J Rehabil Res. 1992;15(2):166-9. doi: 10.1097/00004356-199206000-00011. No abstract available.

    PMID: 1526706BACKGROUND

  • Frakking TT, Chang AB, O'Grady KF, David M, Walker-Smith K, Weir KA. The Use of Cervical Auscultation to Predict Oropharyngeal Aspiration in Children: A Randomized Controlled Trial. Dysphagia. 2016 Dec;31(6):738-748. doi: 10.1007/s00455-016-9727-5. Epub 2016 Jul 11.

    PMID: 27402004BACKGROUND

  • Dawes C, Pedersen AM, Villa A, Ekstrom J, Proctor GB, Vissink A, Aframian D, McGowan R, Aliko A, Narayana N, Sia YW, Joshi RK, Jensen SB, Kerr AR, Wolff A. The functions of human saliva: A review sponsored by the World Workshop on Oral Medicine VI. Arch Oral Biol. 2015 Jun;60(6):863-74. doi: 10.1016/j.archoralbio.2015.03.004. Epub 2015 Mar 10.

    PMID: 25841068BACKGROUND

  • Clancy KJ, Hustad KC. Longitudinal changes in feeding among children with cerebral palsy between the ages of 4 and 7 years. Dev Neurorehabil. 2011;14(4):191-8. doi: 10.3109/17518423.2011.568467.

    PMID: 21732803BACKGROUND

  • Calis EA, Veugelers R, Sheppard JJ, Tibboel D, Evenhuis HM, Penning C. Dysphagia in children with severe generalized cerebral palsy and intellectual disability. Dev Med Child Neurol. 2008 Aug;50(8):625-30. doi: 10.1111/j.1469-8749.2008.03047.x.

    PMID: 18754902BACKGROUND

  • Burkhead LM, Sapienza CM, Rosenbek JC. Strength-training exercise in dysphagia rehabilitation: principles, procedures, and directions for future research. Dysphagia. 2007 Jul;22(3):251-65. doi: 10.1007/s00455-006-9074-z. Epub 2007 Apr 25.

    PMID: 17457549BACKGROUND

  • Boel L, Pernet K, Toussaint M, Ides K, Leemans G, Haan J, Van Hoorenbeeck K, Verhulst S. Respiratory morbidity in children with cerebral palsy: an overview. Dev Med Child Neurol. 2019 Jun;61(6):646-653. doi: 10.1111/dmcn.14060. Epub 2018 Oct 15.

    PMID: 30320434BACKGROUND

  • Blair E, Watson L, Badawi N, Stanley FJ. Life expectancy among people with cerebral palsy in Western Australia. Dev Med Child Neurol. 2001 Aug;43(8):508-15. doi: 10.1017/s0012162201000949.

    PMID: 11508916BACKGROUND

  • Bax M, Tydeman C, Flodmark O. Clinical and MRI correlates of cerebral palsy: the European Cerebral Palsy Study. JAMA. 2006 Oct 4;296(13):1602-8. doi: 10.1001/jama.296.13.1602.

    PMID: 17018805BACKGROUND

  • Kaviyani Baghbadorani M, Soleymani Z, Dadgar H, Salehi M. The effect of oral sensorimotor stimulations on feeding performance in children with spastic cerebral palsy. Acta Med Iran. 2014;52(12):899-904.

    PMID: 25530052BACKGROUND

  • Arvedson J, Clark H, Lazarus C, Schooling T, Frymark T. The effects of oral-motor exercises on swallowing in children: an evidence-based systematic review. Dev Med Child Neurol. 2010 Nov;52(11):1000-13. doi: 10.1111/j.1469-8749.2010.03707.x.

    PMID: 20497451BACKGROUND

MeSH Terms

Conditions

Deglutition DisordersCerebral Palsy

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Marwa Abd Elmawgood Abdo Ragab, BSc.

CONTACT

+201018466190m.elshafie15@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 6, 2025

First Posted

January 21, 2025

Study Start

February 1, 2025

Primary Completion

July 30, 2025

Study Completion

August 30, 2025

Last Updated

January 21, 2025

Record last verified: 2025-01