Back to resultsEffect of Functional Chewing Training on Tongue Thrust and Drooling in Children With Cerebral Palsy
Primary Purpose
Mastication Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Functional Chewing Training
Classical Oral Motor Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Mastication Disorder focused on measuring drooling, tongue thrust
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Functional Chewing Training
Control
Arm Description
Children with CP and have tongue thrust included this group.
Children with CP and have tongue thrust included this group.
Outcomes
Primary Outcome Measures
Tongue Thrust Rating Scale
Tongue thrust for each child is scored while they are feeding.
Secondary Outcome Measures
The Drooling Severity and Frequency Scale
Parents were asked how often and in which severity experiencing drooling their children.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03194048
Brief Title
Effect of Functional Chewing Training on Tongue Thrust and Drooling in Children With Cerebral Palsy
Official Title
Effect of Functional Chewing Training on Tongue Thrust and Drooling in Children With Cerebral Palsy: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 16, 2015 (Actual)
Primary Completion Date
December 20, 2015 (Actual)
Study Completion Date
April 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study examined the effect of Functional Chewing Training(FuCT) on tongue thrust and drooling in children with cerebral palsy.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastication Disorder
Keywords
drooling, tongue thrust
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Functional Chewing Training
Arm Type
Experimental
Arm Description
Children with CP and have tongue thrust included this group.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Children with CP and have tongue thrust included this group.
Intervention Type
Other
Intervention Name(s)
Functional Chewing Training
Other Intervention Name(s)
FuCT
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Classical Oral Motor Exercises
Intervention Description
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 Measure Information:
Title
Tongue Thrust Rating Scale
Description
Tongue thrust for each child is scored while they are feeding.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The Drooling Severity and Frequency Scale
Description
Parents were asked how often and in which severity experiencing drooling their children.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Özgü İnal
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
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.
Results Reference
background
Learn more about this trial
Effect of Functional Chewing Training on Tongue Thrust and Drooling in Children With Cerebral Palsy
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