Chewing Function in Pediatric Neuromuscular Disorders
1 other identifier
interventional
68
1 country
1
Brief Summary
We aimed to evaluate chewing function (CF) in children with neuromuscular disorders, and investigate reliability of the Karaduman Chewing Performance Scale (KCPS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2017
CompletedFirst Posted
Study publicly available on registry
April 17, 2017
CompletedStudy Start
First participant enrolled
May 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2017
CompletedJanuary 3, 2018
December 1, 2017
2 months
April 11, 2017
December 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Chewing evaluation
EXPERIMENTALChildren 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Children above the age of 2 years
- Children with neuromuscular disorders
You may not qualify if:
- Children under the age of 2 years
- Children without neuromuscular disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacetttepe University
Ankara, 06100, Turkey (Türkiye)
Study Officials
- PRINCIPAL INVESTIGATOR
SELEN SEREL ARSLAN, PhD
Hacettepe University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 11, 2017
First Posted
April 17, 2017
Study Start
May 15, 2017
Primary Completion
July 15, 2017
Study Completion
July 15, 2017
Last Updated
January 3, 2018
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share