This study aims to visualize the muscles activated during standard exercises performed with and without the SEA using T2 mapping with MRI in patients who underwent TL. Other aims of this study focus on anatomical variations between the TL patients…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Hoofdhalskankerpatienten die een totale laryngectomie hebben ondergaan
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
anatomical variations
Background summary
After total laryngectomy (TL), 72% of patients report long-term swallowing
problems. The altered anatomy, in which some crucial muscles involved in
swallowing are removed or transected, results in an altered transit of the
bolus through the pharynx, stenosis of the newly created pharynx (neopharynx),
poor pressure build-up at the tongue base, and loss of coordinated muscular
contraction in the neopharynx. Different swallow exercises with and without
resistance, using the swallow exercise aid (SEA), have shown to be effective in
restoring swallowing function in patients with oropharyngeal dysphagia.
However, these exercises have never been evaluated in the TL population. Due to
the altered anatomy, information about which muscles are activated by
conventional exercises and exercises against resistance is lacking. We
hypothesize that training with the SEA activates the same muscles as
traditional exercises. However, we assume that training with the SEA leads to
more intense muscle activation.
Study objective
This study aims to visualize the muscles activated during standard exercises
performed with and without the SEA using T2 mapping with MRI in patients who
underwent TL. Other aims of this study focus on anatomical variations between
the TL patients and compare these variations with swallowing complaints and
surgical techniques.
Study design
Pilot study with a pre- and post-test, explorative biomechanical design
To analyze which muscles are activated by conventional swallow exercise
training and swallow exercise training against resistance with the metal-free
plastic SEA, the MRI will be used. Dry swallow and six exercises will be
investigated on the same day in a fixed order with resting periods to avoid the
effects of the previous exercise disturbing the results of the next exercise.
The exercises in the specified order are 1) Dry swallow, 2) Conventional
Effortful Swallow (cES), 3) Masako, 4) Shaker, 5) Chin Tuck against resistance
(CTAR+), 6) Jaw Opening against resistance (JOAR+) and 7) Effortful Swallow
against resistance (ES+). Firstly, the participant will be asked to relax in a
supine position, and the first MRI scan will be done. Then the participant is
asked to perform one of the exercises until exhaustion, meaning that the
participant cannot perform another repetition of the exercise. Directly after
completing the exercise until exhaustion, the second MRI scan will be made.
Study burden and risks
The burden consists of the time it takes to participate: approximately 140
minutes. The risk of participating in this study is mainly muscle pain after
performing swallowing exercises until exhaustion. Health risks do not accompany
the MRI itself. The participant will not benefit from participating in this
study. However, the results of this study are relevant for TL participants.
This information can be used to optimize the training program.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
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®
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL78467.031.21 |