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Clinical Trials/NCT06343922
NCT06343922
Recruiting
Not Applicable

Effects Of Oral Motor Facilitation Technique And Traditional Exercises On Drooling And Feeding Skills Of Children With Cerebral Palsy

Riphah International University1 site in 1 country10 target enrollmentDecember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy (CP)
Sponsor
Riphah International University
Enrollment
10
Locations
1
Primary Endpoint
Change in Drooling
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
April 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Drooling

Time Frame: 16 weeks

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.

Change in feeding skills

Time Frame: 16 weeks

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.

Study Sites (1)

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