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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04199546
Other study ID # KA-94678
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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