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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03241160
Other study ID # HACETTEPE
Secondary ID
Status Completed
Phase N/A
First received August 2, 2017
Last updated September 8, 2017
Start date August 5, 2017
Est. completion date September 8, 2017

Study information

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

Clinical Trial Summary

The study is planned to determine the relationship between chewing performance level and gross motor function, and trunk postural control in cerebral palsy (CP).


Description:

The study is planned to determine the relationship between chewing performance level and gross motor function, and trunk postural control in cerebral palsy (CP). Chewing performance level will be determined by the chewing performance scale. The Gross Motor Function Classification System (GMFCS) will be used to determine gross motor function levels. Segmental Assessment of Trunk Control (SATCo) will be used to measure trunk control. The correlations between chewing performance level and gross motor function, and trunk postural control will be assessed. The Chi-square test will also be used to compare GMFCS levels and trunk control in children with and without chewing disorders.


Recruitment information / eligibility

Status Completed
Enrollment 119
Est. completion date September 8, 2017
Est. primary completion date September 8, 2017
Accepts healthy volunteers
Gender All
Age group 2 Years to 12 Years
Eligibility Inclusion Criteria:

- Having a diagnosis of cerebral palsy

- Referring by a pediatric neurologist

- Aging between 2 to 12 years

Exclusion Criteria:

- Aging under the age of 24 months

- Using any medicine and/or oral appliances that could affect the chewing performance

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Chewing evaluation
Chewing evaluation will be performed. An experienced physical therapist who will take a scale training session will do the chewing evaluation according to the chewing performance scale.This scale classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing.

Locations

Country Name City State
Turkey Hacetttepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chewing evaluation Chewing evaluation will be determined by a scale that classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing. 15 days
Secondary Gross motor function evaluation Gross motor function evaluation will be performed according to the Gross Motor Function Classification System. 15 days
Secondary Trunk control evaluation Segmental Assessment of Trunk Control (SATCo) will be performed. 15 days
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