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NCT03116620 Clinical Trial

Chewing Function in Pediatric Neuromuscular Disorders

Mastication Disorder Clinical Trial

Official title:
Chewing Function in Pediatric Neuromuscular Disorders

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03116620
Other study ID # Chewing in pediatric NMD
Secondary ID
Status Completed
Phase N/A
First received April 11, 2017
Last updated December 30, 2017
Start date May 15, 2017
Est. completion date July 15, 2017

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

Clinical Trial Summary

We aimed to evaluate chewing function (CF) in children with neuromuscular disorders, and investigate reliability of the Karaduman Chewing Performance Scale (KCPS).

Description:

Chewing disorders (CD) can be seen due to muscle weakness in children with neuromuscular disorders neuromuscular disorders (NMD). Normal diet consists of all food consistencies including liquid, pudding and solid foods, and CD causes inability to intake solid food. This condition can affect development, nutritional behavior and child-parent interaction in children. Thus, it is important to determine CD in an early period with appropriate assessment methods and plan appropriate therapies in NMD. We aimed to evaluate chewing function (CF) in children with NMD, and investigate reliability of the Karaduman Chewing Performance Scale (KCPS).

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date July 15, 2017
Est. primary completion date July 15, 2017
Accepts healthy volunteers No
Gender All
Age group 2 Years to 20 Years
Eligibility Inclusion Criteria:

- Children above the age of 2 years

- Children with neuromuscular disorders

Exclusion Criteria:

- Children under the age of 2 years

- Children without neuromuscular disorders

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Chewing evaluation
Children with neuromuscular disorders (NMD) will be participated. Children will be asked to chew a standardized biscuit while video recording. Two physical therapists will assess all video recordings independently and score each video according to the KCPS. The correlation between the KCPS scores of two therapists will be used for interobserver reliability. One therapist will rescore the recordings after an interval of 2 weeks for intraobserver reliability.

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 The reliability of the KCPS in children with neuromuscular disorders Children with neuromuscular disorders (NMD) will be participated. Children will be asked to chew a standardized biscuit while video recording. Two physical therapists will assess all video recordings independently and score each video according to the KCPS. The correlation between the KCPS scores of two therapists will be used for interobserver reliability. One therapist will rescore the recordings after an interval of 2 weeks for intraobserver reliability. 1 month
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