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

NCT06343922 | Recruiting

• 1 other identifier: Sadaf Riphah
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cerebral Palsy (CP)

Outcome Measures

Primary Outcomes (2)

• Change in Drooling

  Change in drooling of CP children will be measured by using "Drooling Impact scale", a quantitative tool to evaluate the effects of intervention on drool control. It is a 10 item scale with 10 point scoring level from 0 (no impact at all) to 10 (severe impact) to quantify the impact of intervention.

  16 weeks

• Change in feeding skills

  A change in oral motor skills during feeding after intervention will be evaluated by using "Oral Motor Assessment Scale", a seven item/variable scale and each variable scores from 0 (not functional ) to 3 ( normal function). At the end total score is measured and an increase in score shows the improvement in feeding skills.

  16 weeks

Study Arms (2)

oral motor facilitation technique group

EXPERIMENTAL

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.

Behavioral: oral motor facilitation technique group

traditional oral motor exercises group

OTHER

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

Other: traditional oral motor exercises group

Interventions

oral motor facilitation technique group BEHAVIORAL

oral motor facilitation technique

oral motor facilitation technique group

traditional oral motor exercises group OTHER

traditional oral motor exercises

traditional oral motor exercises group

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• CP children with other co morbidities or syndromes
• risk of aspiration
• children on tube feeding or with seizures
• children with craniofacial anomalies

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Mobilty Quest

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (5)

• 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.

  PMID: 34733374 BACKGROUND

• 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.

  PMID: 36324103 BACKGROUND

• 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.

  PMID: 33960181 BACKGROUND

• 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.

  PMID: 19843155 BACKGROUND

• 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.

  PMID: 19627455 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Nazia Mumtaz, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazia Mumtaz, Phd

CONTACT

03335196500; nazia.mumtaz@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: April 3, 2024
• Study Start: December 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)