Chewing and Swallowing Training Program in Coffin-Lowry Syndrome

Not Applicable

Completed

• Conditions: Chewing Problem; Swallowing Disorder
• Interventions: Other: Chewing and swallowing rehabilitation

• Registration Number: NCT04199546
• Lead Sponsor: Hacettepe University

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-12-12
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-16
• Status Verified: 2020-06
• Primary Completion: 2020-06-19
• Study Completion: 2020-06-19
• Last Update Submitted: 2020-06-30
• Last Update Posted: 2020-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1

Inclusion Criteria

• Having a diagnosis of CLS
• Having a history of coughing during eating, long-lasting wheezing, sputum
• Inability to intake solid food.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A child with Coffin-Lowry Syndrome	Chewing and swallowing rehabilitation	A 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.

Primary Outcome Measures

Name	Time	Method
Instrumental swallowing evaluation	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Swallowing screening	6 months	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.
Chewing evaluation	6 months	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.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey