The Swallowing Exercise Aid in Total Laryngectomy: Feasibility, Adherence and a Multidimensional Assessment of Functional-, Physical-, and Patient-reported outcomes

Completed

Conditions: Hoofdhalskankerpatienten die een totale laryngectomie hebben ondergaan
Larynx extirpation
dysphagia

Registration Number: NL-OMON50048

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

• >= 18 years or older
• Undergone a TLE
• At least six months post TLE
• At least six months postoperative (chemo-) radiotherapy (if applicable)
• Using Tracheoesophageal speech
• Oral intake of a modified diet (FOIS 2 - 6) or who experience swallowing
problems
• Signed informed consent

Exclusion Criteria

• Unable to understand the patient information
• Unable to understand the informed consent
• Unable to comprehend and use the SEA
• Unable or unwilling to provide informed consent
• Neuro-degenerative diseases, for instance, dementia, Parkinson, Korsakov

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This study has a multidimensional assessment approach, including feasibility<br /><br>and adherence, physical outcomes, functional outcomes, and patient-reported<br /><br>outcomes. In this study, measures of interest are muscle strength,<br /><br>manofluorography, manometry, voice recordings, dynamic range of voice, maximum<br /><br>fonation time, questionnaires, and information from the electronic medical<br /><br>files. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary: (Multidimensional Evaluation)<br /><br>Physical outcomes:<br /><br>- Strength measurement (IOPI, dynamometer)<br /><br>- Manofluorography<br /><br>- Pressure measurement during breathing and vocalization (manometry)<br /><br>Functional Outcomes:<br /><br>- Voice recordings<br /><br>- Mouth opening<br /><br>Subjective outcomes:<br /><br>- Questionnaires on Quality of life, swallowing problems, voice problems,<br /><br>participation</p><br>