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Trial record 17 of 5223 for:    neuromuscular disease

Chewing Function in Pediatric Neuromuscular Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03116620
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
SELEN SEREL ARSLAN, Hacettepe University

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

Condition or disease Intervention/treatment Phase
Mastication Disorder Other: Chewing evaluation Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Chewing Function in Pediatric Neuromuscular Disorders
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : July 15, 2017
Actual Study Completion Date : July 15, 2017

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Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. The reliability of the KCPS in children with neuromuscular disorders [ Time Frame: 1 month ]
    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.



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Ages Eligible for Study:   2 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116620


Locations
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Turkey
Hacetttepe University
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: SELEN SEREL ARSLAN, PhD Hacettepe University

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Responsible Party: SELEN SEREL ARSLAN, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT03116620     History of Changes
Other Study ID Numbers: Chewing in pediatric NMD
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SELEN SEREL ARSLAN, Hacettepe University:
mastication
children with neuromuscular disorders
Additional relevant MeSH terms:
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Neuromuscular Diseases
Disease
Pathologic Processes
Nervous System Diseases