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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03194048
Other study ID # özgü inal
Secondary ID
Status Completed
Phase N/A
First received June 13, 2017
Last updated June 19, 2017
Start date December 16, 2015
Est. completion date April 1, 2016

Study information

Verified date June 2017
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date April 1, 2016
Est. primary completion date December 20, 2015
Accepts healthy volunteers No
Gender All
Age group 4 Years to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

References & Publications (1)

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Tongue Thrust Rating Scale Tongue thrust for each child is scored while they are feeding. 12 weeks
Secondary The Drooling Severity and Frequency Scale Parents were asked how often and in which severity experiencing drooling their children. 12 weeks
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