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

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ClinicalTrials.gov Identifier: NCT03194048
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Özgü İNAL, Hacettepe University

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

Condition or disease Intervention/treatment Phase
Mastication Disorder Other: Functional Chewing Training Other: Classical Oral Motor Exercises Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Functional Chewing Training on Tongue Thrust and Drooling in Children With Cerebral Palsy: A Randomised Controlled Trial
Actual Study Start Date : December 16, 2015
Actual Primary Completion Date : December 20, 2015
Actual Study Completion Date : April 1, 2016

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Tongue Thrust Rating Scale [ Time Frame: 12 weeks ]
    Tongue thrust for each child is scored while they are feeding.


Secondary Outcome Measures :
  1. The Drooling Severity and Frequency Scale [ Time Frame: 12 weeks ]
    Parents were asked how often and in which severity experiencing drooling their children.



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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194048


Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Özgü İnal Hacettepe University

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.

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Responsible Party: Özgü İNAL, Hacettepe University
ClinicalTrials.gov Identifier: NCT03194048     History of Changes
Other Study ID Numbers: özgü inal
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Özgü İNAL, Hacettepe University:
drooling
tongue thrust
Additional relevant MeSH terms:
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Sialorrhea
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases