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CompletedNCT03194048Updated Jun 21, 2017

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

An interventional study of Functional Chewing Training and Classical Oral Motor Exercises in Mastication Disorder, sponsored by Hacettepe University. Completed. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2017-06-21.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
4 Years to 6 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Mastication Disorder

Keywords

  • drooling
  • tongue thrust
03

Who can participate

Ages eligible
4 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • children who were unable the sitting position
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Functional Chewing Training

    Children with CP and have tongue thrust included this group.

    Other: Functional Chewing Training

  • Active comparator
    Control

    Children with CP and have tongue thrust included this group.

    Other: Classical Oral Motor Exercises

Interventions

  • OtherFunctional 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

    Also known as: FuCT

  • OtherClassical 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

05

What researchers measure

Primary outcomes

  1. Tongue Thrust Rating Scale

    Tongue thrust for each child is scored while they are feeding.

    Time frame: 12 weeks

Secondary outcomes

  1. The Drooling Severity and Frequency Scale

    Parents were asked how often and in which severity experiencing drooling their children.

    Time frame: 12 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

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.

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03194048
Lead sponsor
Hacettepe University
Responsible party
Özgü İNAL (Özgü İNAL, Hacettepe University) — Principal investigator
First posted
Jun 21, 2017
Start date
Dec 16, 2015
Primary completion
Dec 20, 2015
Completion
Apr 1, 2016
Last update
Jun 21, 2017

Study contacts

Özgü İnal
principal investigator · Hacettepe University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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