Effect of Functional Chewing Training on Tongue Thrust and Drooling in Children With Cerebral Palsy
1 other identifier
interventional
32
0 countries
N/A
Brief Summary
This study examined the effect of Functional Chewing Training(FuCT) on tongue thrust and drooling in children with cerebral palsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 13, 2017
CompletedFirst Posted
Study publicly available on registry
June 21, 2017
CompletedJune 21, 2017
June 1, 2017
4 days
June 13, 2017
June 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tongue Thrust Rating Scale
Tongue thrust for each child is scored while they are feeding.
12 weeks
Secondary Outcomes (1)
The Drooling Severity and Frequency Scale
12 weeks
Study Arms (2)
Functional Chewing Training
EXPERIMENTALChildren with CP and have tongue thrust included this group.
Control
ACTIVE COMPARATORChildren with CP and have tongue thrust included this group.
Interventions
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; * Family training * passive and active lip and tongue exercises, for 12 weeks in 5 sets (1 set = 20 min) each day
Eligibility Criteria
You may qualify if:
- diagnosed with cerebral palsy
- aged between 4-6 years
- fed by orally
- had tongue thrust
You may not qualify if:
- children who were unable the sitting position
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Özgü İnal
Hacettepe University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Özgü İNAL
Study Record Dates
First Submitted
June 13, 2017
First Posted
June 21, 2017
Study Start
December 16, 2015
Primary Completion
December 20, 2015
Study Completion
April 1, 2016
Last Updated
June 21, 2017
Record last verified: 2017-06