Effect of Functional Chewing Training on Tongue Thrust and Drooling in Children With Cerebral Palsy

Effect of Functional Chewing Training on Tongue Thrust and Drooling in Children With Cerebral Palsy: A Randomised Controlled Trial

This study examined the effect of Functional Chewing Training(FuCT) on tongue thrust and drooling in children with cerebral palsy.

Study Overview

• Status: Completed
• Conditions: Mastication Disorder
• Intervention / Treatment: Other: Functional Chewing Training; Other: Classical Oral Motor Exercises

Detailed Description

Children were divided into two groups: The FuCT group and control group receiving classical oral motor exercises. Each group received training for 12 weeks. Oral motor assessment was performed. Chewing performance level was determined with the Karaduman Chewing Performance Scale(KCPS). Tongue thrust severity was evaluated with the Tongue Thrust Rating Scale(TTRS). The Drooling Severity and Frequency Scale(DSFS) was used to evaluate drooling severity and frequency. The evaluations were performed before and after treatment.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosed with cerebral palsy
• aged between 4-6 years
• fed by orally
• had tongue thrust

Exclusion Criteria:

• children who were unable the sitting position

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional Chewing Training; Children with CP and have tongue thrust included this group.	Other: Functional Chewing Training; FuCT; Family training; Providing optimal sitting posture for children to support oral sensorimotor functions; Positioning the food to the molar area during every meal to stimulate lateral and rotational tongue movements; Massage of the upper and lower gums through the front teeth to molar area; Chewing training to stimulate lateral and rotational tongue movements; Gradually increasing the food consistency, for 12 weeks in 5 sets (1 set = 20 min) each day; Other Names: FuCT
Active Comparator: Control; Children with CP and have tongue thrust included this group.	Other: Classical Oral Motor Exercises; Classical Oral Motor Exercises; Family training; passive and active lip and tongue exercises, for 12 weeks in 5 sets (1 set = 20 min) each day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tongue Thrust Rating Scale	Tongue thrust for each child is scored while they are feeding.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Drooling Severity and Frequency Scale	Parents were asked how often and in which severity experiencing drooling their children.	12 weeks

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Özgü İnal, Hacettepe University

Publications and helpful links

General Publications

• Rempel GR, Colwell SO, Nelson RP. Growth in children with cerebral palsy fed via gastrostomy. Pediatrics. 1988;82:857-862. Allen MC, Capute A. The evolution of primitive reflexes in extremely premature infants. Pediatr Res. 1986;20:1284-1289. Blasco PA. Primitive reflexes: their contribution to the early detection of cerebral palsy. Clinical pediatrics. 1994;33:388-397. Singh S, Dua P, Jain S. Habit breaking appliance for tongue thrusting-a modification. Indian J Dent Sci. 2011;3:10.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2015
• Primary Completion (Actual): December 20, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: drooling; tongue thrust
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Cerebral Palsy; Sialorrhea
• Other Study ID Numbers: özgü inal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No