Back to resultsChewing Function in Pediatric Neuromuscular Disorders
Primary Purpose
Mastication Disorder
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Chewing evaluation
Sponsored by
About this trial
This is an interventional other trial for Mastication Disorder focused on measuring mastication, children with neuromuscular disorders
Eligibility Criteria
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
Sites / Locations
- Hacetttepe University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chewing evaluation
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03116620
Brief Title
Chewing Function in Pediatric Neuromuscular Disorders
Official Title
Chewing Function in Pediatric Neuromuscular Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
July 15, 2017 (Actual)
Study Completion Date
July 15, 2017 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We aimed to evaluate chewing function (CF) in children with neuromuscular disorders, and investigate reliability of the Karaduman Chewing Performance Scale (KCPS).
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastication Disorder
Keywords
mastication, children with neuromuscular disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chewing evaluation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Chewing evaluation
Intervention Description
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.
Primary Outcome Measure Information:
Title
The reliability of the KCPS in children with neuromuscular disorders
Description
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.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SELEN SEREL ARSLAN, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacetttepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chewing Function in Pediatric Neuromuscular Disorders
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