Chewing and Swallowing Training Program in Coffin-Lowry Syndrome
1 other identifier
interventional
1
1 country
1
Brief Summary
This study will report the chewing and swallowing disorders of a Coffin-Lowry Syndrome (CLS) patient, and effects of chewing and swallowing training on chewing and swallowing function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2019
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2019
CompletedStudy Start
First participant enrolled
December 12, 2019
CompletedFirst Posted
Study publicly available on registry
December 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2020
CompletedJuly 1, 2020
June 1, 2020
6 months
December 12, 2019
June 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Instrumental swallowing evaluation
Videofluoroscopic Swallowing Evaluation (VFSE) will be performed. The swallowing physiology will be evaluated by using 3 ml of liquid and pudding barium during the VFSE. The Penetration and Aspiration Scale (PAS) will be used to determine penetration and aspiration severity, which is scored between 1 to 8. The score of PAS 1 means 'No aspiration', scores from 2 to 5 indicate 'Penetration', and scores from 6 to 8 indicate 'Aspiration'. High score indicates bad situation.
6 months
Secondary Outcomes (2)
Swallowing screening
6 months
Chewing evaluation
6 months
Study Arms (1)
A child with Coffin-Lowry Syndrome
OTHERA boy with a known CLS diagnosis with a history of coughing during eating, long-lasting wheezing, sputum and inability to intake solid food will be included.
Interventions
A home based chewing and swallowing training program (CST) will be applied by an experienced physical therapist. The Functional Chewing Training will be used to improve chewing function which has five steps including positioning the child and food, sensory stimulation, chewing training and adjustment of food consistency to improve chewing function. To support hyolaryngeal elevation, laryngeal mobilization will be performed. Hyolaryngeal mobilization will be performed by moving hyolaryngeal complex in right, left and up directions manually.
Eligibility Criteria
You may qualify if:
- Having a diagnosis of CLS
- Having a history of coughing during eating, long-lasting wheezing, sputum
- Inability to intake solid food.
You may not qualify if:
- \- No history of coughing during eating, long-lasting wheezing, sputum
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
AYŞE KÜBRA ŞAHAN
Hacettepe University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
December 12, 2019
First Posted
December 16, 2019
Study Start
December 12, 2019
Primary Completion
June 19, 2020
Study Completion
June 19, 2020
Last Updated
July 1, 2020
Record last verified: 2020-06