Chewing and Swallowing Training Program in Coffin-Lowry Syndrome

Swallowing Disorder Clinical Trial

Official title:

Chewing and Swallowing Training Program in Coffin-Lowry Syndrome: A Case Report

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04199546
• Other study ID #: KA-94678
• Status: Completed
• Phase: N/A
• Start date: December 12, 2019
• Est. completion date: June 19, 2020

Study information

• Verified date: June 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients with CLS suffer from spinal deformities, nonconvulsive status epilepticus, obstructive sleeep apnea syndrome, pneumonia, stimulus-induced myoclonus, cases of falls, mechanical ventilation, restrictive lung disease. It was also reported that patients with CLS had problems with eating and feeding functions. However there is no study investigating chewing and swallowing functions of this patient population. Therefore, the investigators have three main purposes:

1. To chewing and swallowing function in a boy with CLS diagnosis who was referred due to coughing during eating, long-lasting wheezing, sputum and inability to intake solid food

2. To investigate the effects of two months of chewing and swallowing training program

3. To present long term follow-up effects on chewing and swallowing function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 19, 2020
• Est. primary completion date: June 19, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 3 Years to 3 Years

Eligibility

Inclusion Criteria:

• Having a diagnosis of CLS

• Having a history of coughing during eating, long-lasting wheezing, sputum

• Inability to intake solid food.

Exclusion Criteria:

• No history of coughing during eating, long-lasting wheezing, sputum

Related Conditions & MeSH terms

• Chewing Problem
• Deglutition Disorders
• Swallowing Disorder

Intervention

Other:
• Chewing and swallowing rehabilitation
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.

Locations

Country	Name	City	State
Turkey	Hacettepe 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	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	Swallowing screening	The Pediatric Eating Assessment Tool (PEDI-EAT-10) instrument which has 10 questions to evaluate dysphagia symptom severity in children will be completed.; Total scoring ranges from 0 to 40. Higher scores mean worse outcome.	6 months
Secondary	Chewing evaluation	Karaduman Chewing Performance Scale will be used to define chewing performance level. It is a 5 point scale between 0 to 4. Level 0 means 'Normal chewing function', and level 4 means 'No biting and chewing'. Higher scores mean worse chewing function.	6 months