MRI Assessment of Muscle Activation with the Swallow Exercise Aid and Conventional Exercises after total laryngectomy: an explorative biomechanical study.
Completed
- Conditions
- Hoofdhalskankerpatienten die een totale laryngectomie hebben ondergaanLarynx extirpation
- Registration Number
- NL-OMON49905
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
- >= 18 years or older
- Undergone a TLE
- At least six months post TLE
- At least six months postoperative (chemo-)radiotherapy
- Complete remission
- 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
- Patients who meet contraindication for MRI, such as the presence of metallic
implants, pacemakers, or claustrophobia
- Patients who use the Provox® ActiValve®
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter contains the change in T2 value of possible involved<br /><br>muscles of the neopharynx at rest and after exercise. Muscles included are the<br /><br>masticatory muscles, intrinsic and extrinsic tongue muscles, supra- and<br /><br>infra-hyoid muscles, palatal muscles, and pharyngeal muscles. </p><br>
- Secondary Outcome Measures
Name Time Method <p>anatomical variations</p><br>