MRI Assessment of Muscle Activation with the Swallow Exercise Aid and Conventional Exercises after total laryngectomy: an explorative biomechanical study.

MRI Assessment of Muscle Activation with the Swallow Exercise Aid and Conventional Exercises after total laryngectomy: an explorative biomechanical study. - SEAM

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49905

Enrollment

Registered

2021-10-15

Start date

2022-07-31

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hoofdhalskankerpatienten die een totale laryngectomie hebben ondergaan Larynx extirpation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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®

Design outcomes

Primary

Measure	Time frame
The main study parameter contains the change in T2 value of possible involved muscles of the neopharynx at rest and after exercise. Muscles included are the masticatory muscles, intrinsic and extrinsic tongue muscles, supra- and infra-hyoid muscles, palatal muscles, and pharyngeal muscles.	—

Secondary

Measure	Time frame
anatomical variations	—

Countries

Netherlands

Outcome results