Tongue Motor Recruitment During Exercise
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|ClinicalTrials.gov Identifier: NCT02687737|
Recruitment Status : Completed
First Posted : February 22, 2016
Last Update Posted : January 5, 2017
The prevalence of dysphagia may be as high as 22% in individuals over 50 years of age. There are few therapeutic options offered to these individuals. One more recent therapeutic option is Expiratory Muscle Strength Training (EMST), which has been used successfully to maintain or increase expiratory force generating pressures, cough function, and swallowing in a number of disease populations. Recently, the investigators have noted improvements in oral transit time during swallowing in individuals with Amyotrophic Lateral Sclerosis (ALS) that could potentially be attributed to improved base of tongue functioning and muscle activation.
There has been one study that demonstrated that breathing training resulted in increased and prolonged submental (under the chin) muscle activation as evidenced by surface electromyography. However, no studies have investigated the activation of the tongue muscles during various swallowing and breathing exercises. A small needle electrode (fine wire EMG) is standard of care in diagnosing muscular diseases because it can determine amount of muscle recruitment for muscles throughout the body. This aim of this research study is to examine the effects of breathing exercises and swallowing exercises on tongue muscle activity in healthy adults.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Procedure: Electromyography Procedure: Maximum expiratory pressure Procedure: Videofluoroscopy Behavioral: Swallowing Tasks||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Genioglossus Motor Recruitment During Swallowing and Expiratory Loading Exercises|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
The participants will have the following tests performed: Maximum Expiratory Pressure (MEP), insertion of a fine-wire electromyography (EMG) electrode into the mid-line base of the tongue, will complete swallowing tasks and breathing tasks under Videofluoroscopy (fluoroscopy on only during the actual task)
During the fine wire electromyography (EMG), the participant will be asked to complete breathing exercises at 50% and 75% of their maximum capacity (determined prior to fine wire EMG using manometry) to determine activation and recruitment of genioglossus muscle.
Other Name: EMG
Procedure: Maximum expiratory pressure
The participants' maximum expiratory pressure (MEP) will be assessed using a hand-held digital manometer (MP01, Micro Direct Inc.). The subject will be standing and while wearing a nose clip be asked to blow out as hard and fast as they can to determine their MEP. This will be completed a maximum of three times to obtain values within close range of one another.
Other Name: MEP
Videofluoroscopy allows for time-synced, frame-by-frame data analysis for the specific measures taken during swallowing tasks.
Other Name: Videofluoroscopy and Barium
Behavioral: Swallowing Tasks
These include: an anterior tongue press to the alveolar ridge (behind the front molars), a saliva swallow, a 10 mL barium swallow, a 10 mL barium "hard" swallow (i.e. swallowing with extra effort), and two breathing exercise trials at 50% MEP and 75% MEP.
- Electromyography (EMG) will be used to analyze genioglossus muscle movement [ Time Frame: Baseline ]Electromyography (EMG) activity will be recorded via standard concentric needle electrodes inserted into the genioglossus muscle. Maximum muscle activation will be recorded and analyzed to determine difference between tasks using the genioglossus muscle.
- Kinematic Swallowing Measurements will be used to analyze a normal movement of swallowing [ Time Frame: Baseline ]Kinematic swallowing measurements is an objective analysis of videofluoroscopy. This involves capturing and manipulating digital images with computer technology to make exact timing measures of bolus flow and movement of structures, as well as spatial measurements of distance and area against reference points.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687737
|United States, Florida|
|Shands Hospital at the University of Florida|
|Gainesville, Florida, United States, 32611|
|Principal Investigator:||Emily K Plowman, PhD, CCC-SLP||University of Florida College of Public Health and Health Professions|