Oral Motor Facilitation Technique And Traditional Exercises on Children With Cerebral Palsy

NCT ID: NCT06343922

Last Updated: 2024-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-04-30

Brief Summary

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Cerebral palsy is a motor disorder caused by the damage to the developing brain. Feeding and swallowing difficulties are common in children with cerebral palsy (CP). Poor postural control and oral motor dysfunction results in extended feeding time, frequent coughing, choking and excessive drooling affecting their health and quality of life. The brain damage in CP is permanent that cannot be fixed however different oral motor exercises, oral facial facilitation and oral sensorimotor interventions are widely used for drool reduction and feeding difficulties in children with CP. Spastic cerebral palsy is one of most prevalent type of CP that is characterized by increased tone and stiffness of muscles. This research will be conducted to evaluate the comparative effects of oral motor facilitation technique (OMFT) and traditional oral motor exercises on drooling and feeding skills of children with spastic CP. OMFT is a complete protocol with a combination of techniques to deal with oral motor difficulties This study will be a randomized control trial. A total number of 12 children with Spastic cerebral palsy ( GMFS III-V) both male/female, between age range 3-12 and with feeding difficulties will be included in the study. Children with cerebral palsy and other co morbidities, seizures, risk of aspiration and who are on tube feeding will be excluded. Participants will be randomly allocated to two groups, either Group A (receiving OMFT) or Group B (receiving traditional oral motor exercise). Baseline scores will be recorded by using standardized tools OMAS for oral motor skill during feeding and DIS for drool severity with the consent of authors. Therapeutic sessions will be scheduled 3 days per week and 30 min a day for each group. The effects of interventions on drooling and feeding skills will be assessed after 8 and 16 weeks of sessions. Recorded data of all variables will be analyzed by using statistical package for social sciences (SPSS) for Windows Software, version 21.

Detailed Description

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Cerebral palsy is a motor disorder caused by the damage to the developing brain. Feeding and swallowing difficulties are common in children with cerebral palsy (CP). Poor postural control and oral motor dysfunction results in extended feeding time, frequent coughing, choking and excessive drooling affecting their health and quality of life. The brain damage in CP is permanent that cannot be fixed however different oral motor exercises, oral facial facilitation and oral sensorimotor interventions are widely used for drool reduction and feeding difficulties in children with CP. Spastic cerebral palsy is one of most prevalent type of CP that is characterized by increased tone and stiffness of muscles. This research will be conducted to evaluate the comparative effects of oral motor facilitation technique (OMFT) and traditional oral motor exercises on drooling and feeding skills of children with spastic CP. OMFT is a complete protocol with a combination of techniques to deal with oral motor difficulties This study will be a randomized control trial. A total number of 12 children with Spastic cerebral palsy ( GMFS III-V) both male/female, between age range 3-12 and with feeding difficulties will be included in the study. Children with cerebral palsy and other co morbidities, seizures, risk of aspiration and who are on tube feeding will be excluded. Participants will be randomly allocated to two groups, either Group A (receiving OMFT) or Group B (receiving traditional oral motor exercise). Baseline scores will be recorded by using standardized tools OMAS for oral motor skill during feeding and DIS for drool severity with the consent of authors. Therapeutic sessions will be scheduled 3 days per week and 30 min a day for each group. The effects of interventions on drooling and feeding skills will be assessed after 8 and 16 weeks of sessions. Recorded data of all variables will be analyzed by using statistical package for social sciences (SPSS) for Windows Software, version 21.

Conditions

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Cerebral Palsy (CP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1 will receive exercises by using oral motor facilitation technique protocol three times a week Group 2 will receive traditional oral motor exercises three times per week
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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oral motor facilitation technique group

Exercise by using OMFT protocol will be given in the order of warming up technique, key point technique and application technique for 30 min a day.

Group Type EXPERIMENTAL

oral motor facilitation technique group

Intervention Type BEHAVIORAL

oral motor facilitation technique

traditional oral motor exercises group

Traditional exercises of lips, cheeks, tongue and jaws will be provided for 30 min a day and 3 days/week

Group Type OTHER

traditional oral motor exercises group

Intervention Type OTHER

traditional oral motor exercises

Interventions

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oral motor facilitation technique group

oral motor facilitation technique

Intervention Type BEHAVIORAL

traditional oral motor exercises group

traditional oral motor exercises

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children with cerebral palsy
* Type: spastic CP
* Severity level :GMFCS (gross motor function classification scale) level III to V, with head and neck control problems
* With feeding and oral motor difficulties
* Gender male/female
* Age: 3-10 years
* No past history of receiving OMFT

Exclusion Criteria

* CP children with other co morbidities or syndromes
* risk of aspiration
* children on tube feeding or with seizures
* children with craniofacial anomalies
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nazia Mumtaz, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Mobilty Quest

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Nazia Mumtaz, Phd

Role: CONTACT

03335196500

Facility Contacts

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Mobility Quest

Role: primary

03336596656

References

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Widman-Valencia ME, Gongora-Meza LF, Rubio-Zapata H, Zapata-Vazquez RE, Lizama EV, Salomon MR, Estrella-Castillo D. Oral Motor Treatment Efficacy: Feeding and Swallowing Skills in Children with Cerebral Palsy. Behav Neurol. 2021 Oct 25;2021:6299462. doi: 10.1155/2021/6299462. eCollection 2021.

Reference Type BACKGROUND
PMID: 34733374 (View on PubMed)

Min KC, Seo SM, Woo HS. Effect of oral motor facilitation technique on oral motor and feeding skills in children with cerebral palsy : a case study. BMC Pediatr. 2022 Nov 3;22(1):626. doi: 10.1186/s12887-022-03674-8.

Reference Type BACKGROUND
PMID: 36324103 (View on PubMed)

Abd-Elmonem AM, Saad-Eldien SS, Abd El-Nabie WA. Effect of oral sensorimotor stimulation on oropharyngeal dysphagia in children with spastic cerebral palsy: a randomized controlled trial. Eur J Phys Rehabil Med. 2021 Dec;57(6):912-922. doi: 10.23736/S1973-9087.21.06802-7. Epub 2021 May 7.

Reference Type BACKGROUND
PMID: 33960181 (View on PubMed)

Reid SM, Johnson HM, Reddihough DS. The Drooling Impact Scale: a measure of the impact of drooling in children with developmental disabilities. Dev Med Child Neurol. 2010 Feb;52(2):e23-8. doi: 10.1111/j.1469-8749.2009.03519.x. Epub 2009 Oct 15.

Reference Type BACKGROUND
PMID: 19843155 (View on PubMed)

Ortega Ade O, Ciamponi AL, Mendes FM, Santos MT. Assessment scale of the oral motor performance of children and adolescents with neurological damages. J Oral Rehabil. 2009 Sep;36(9):653-9. doi: 10.1111/j.1365-2842.2009.01979.x. Epub 2009 Jul 15.

Reference Type BACKGROUND
PMID: 19627455 (View on PubMed)

Other Identifiers

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Sadaf Riphah

Identifier Type: -

Identifier Source: org_study_id

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