Pharyngeal Exerciser for Swallowing Disorders
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical College of Wisconsin
Disqualifiers: Neurological disorders, Muscle diseases, Esophageal symptoms, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study of healthy young and elderly individuals is intended to assess the effects of pharyngeal exerciser on pharyngeal pressure phenomenon during swallowing. Our specific aim is to test if the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the Pharyngeal Exerciser treatment for swallowing disorders?
Research shows that exercises like the Shaker Exercise, which is part of the Pharyngeal Exerciser treatment, can improve swallowing function in patients with swallowing difficulties. Studies have demonstrated improvements in swallowing function in stroke patients and those with head and neck cancer after performing similar exercises.
12345Is the Pharyngeal Exerciser safe for humans?
Studies involving devices similar to the Pharyngeal Exerciser, like the Laryngeal Restriction Device, have been conducted on healthy adults and have not reported any safety concerns. These studies focused on the effects of resistance exercises on swallowing muscles, and while they showed changes in muscle function, no adverse effects were noted.
12678How is the Pharyngeal Exerciser treatment different from other treatments for swallowing disorders?
The Pharyngeal Exerciser is unique because it is an external device designed to specifically target and strengthen the muscles involved in swallowing, unlike other treatments that may focus on general exercises or oral exercises. This device offers a novel approach by providing targeted resistance to improve swallowing function.
1291011Eligibility Criteria
This trial is for healthy individuals aged 18 or older who have no history of head or neck surgery, significant bleeding disorders, autonomic dysfunction, carotid vascular disorders, neuro-muscular junction disorders like myasthenia gravis, esophageal symptoms (e.g., heartburn), allergies to lidocaine and barium, severe medical conditions such as COPD or cancer, cervical spine or neurological disorders excluding Parkinson's Disease.Inclusion Criteria
Healthy volunteers must be at least 18 years of age or older.
Exclusion Criteria
Subjects who are medically unstable.
You have a condition where your body's automatic functions, like heart rate and blood pressure, don't work properly.
Subjects with significant bleeding disorders for whom nasal intubation has been deemed contraindicated
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
Baseline Assessment
Participants undergo baseline assessments including physical examination and measurement of neck and device dimensions
1 day
1 visit (in-person)
Treatment
Participants perform swallowing exercises with the pharyngeal exerciser under varying pressures, with optional videofluoroscopic examination
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 week
Participant Groups
The study is examining the impact of a pharyngeal exerciser on swallowing pressure in both young and elderly healthy volunteers. It aims to determine whether this device can increase muscle workload during the pharyngeal phase of swallowing.
1Treatment groups
Experimental Treatment
Group I: Pharyngeal exerciser groupExperimental Treatment1 Intervention
Test that application of the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing as evidenced manometrically by changes in
Pharyngeal peak pressures Pharyngeal (velopharynx, oropharynx and hypopharynx) contractile duration Pharyngeal (velopharynx, oropharynx and hypopharynx) contractile integral Hypopharyngeal intrabolus pressure and duration UES nadir pressure UES relaxation time Baseline UES pressure
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical College of WisconsinMilwaukee, WI
Loading ...
Who Is Running the Clinical Trial?
Medical College of WisconsinLead Sponsor
References
Effects of bedside self-exercise on oropharyngeal swallowing function in stroke patients with dysphagia: a pilot study. [2020][Purpose] The purpose of this study was to investigate the effect of self-exercise on oropharyngeal swallowing function in patients with dysphagia. [Subjects and Methods] Nine patients with dysphagia after stroke were recruited. Self-exercise including effortful swallowing, tongue strengthening, and shaker exercise was performed 5 times a week for 4 weeks. Swallowing function was evaluated using the videofluoroscopic dysphagia scale (VDS) based on a videofluoroscopic swallowing study. [Results] There were significant differences in both the oral and pharyngeal phases of the VDS before and after the intervention. [Conclusion] This study demonstrated that bedside self-exercise is a positive method to improve oropharyngeal swallowing function in patients with dysphagia after stroke.
Proposal for a Modified Jaw Opening Exercise for Dysphagia: A Randomized, Controlled Trial. [2017]To verify the feasibility and effectiveness of a newly developed modified jaw opening exercise (MJOE) in post-stroke patients with pharyngeal residue who completed a sixweek exercise regimen.
Attaining and maintaining isometric and isokinetic goals of the Shaker exercise. [2022]Previous studies have shown that the Shaker Exercise is effective in restoring oral intake in patients with deglutitive failure due to upper esophageal sphincter (UES) dysfunction. Our aim was to determine (1) exerciser compliance among healthy older adults, (2) number of days required to attain the isometric (IM) and isokinetic (IK) exercise goals, (3) rate and reason for dropout of exercisers, and (4) complaints associated with performance of the exercise. Twenty-six nondysphagic older adults were enrolled from an independent-living community (66-93 yr) to perform the Shaker Exercise. Each participant completed a questionnaire on exercise performance and its associated difficulties three times a day for six weeks. Four randomly chosen nondysphagic participants underwent pre- and postexercise videofluoroscopic swallow studies for biomechanical measurements. Maximum anterior hyoid and laryngeal excursions, as well as maximum anteroposterior UES opening increased (p
Case study: application of isometric progressive resistance oropharyngeal therapy using the Madison Oral Strengthening Therapeutic device. [2022]Isometric progressive resistance oropharyngeal (I-PRO) therapy improves swallowing function; however, current devices utilize a single sensor that provides limited information or are prohibitively expensive. This single-subject study presents results of I-PRO therapy, detraining, and maintenance using the 5-sensor Madison Oral Strengthening Therapeutic (MOST) device combined with upper esophageal sphincter (UES) dilatation.
The effect of the Shaker head-lift exercise on swallowing function following treatment for head and neck cancer: Results from a randomized, controlled trial with videofluoroscopic evaluation. [2022]Dysphagia is common following treatment for head and neck cancer (HNC) and intervention to improve swallowing function is warranted. This study aimed to evaluate the efficacy of the Shaker head-lift exercise (HLE) to improve dysphagia in HNC patients.
Effects of laryngeal restriction on pharyngeal peristalsis and biomechanics: Clinical implications. [2019]To date, rehabilitative exercises aimed at strengthening the pharyngeal muscles have not been developed due to the inability to successfully overload and fatigue these muscles during their contraction, a necessary requirement for strength training. The purpose of this study was to test the hypothesis that applying resistance against anterosuperior movement of the hyolaryngeal complex will overload the pharyngeal muscles and by repetitive swallowing will result in their fatigue manifested by a reduction in pharyngeal peristaltic amplitude. Studies were done in two groups. In group 1 studies 15 healthy subjects (age: 42 ± 14 yr, 11 females) were studied to determine whether imposing resistance to swallowing using a handmade device can affect the swallow-induced hyolaryngeal excursion and related upper esophageal sphincter (UES) opening. In group 2, an additional 15 healthy subjects (age 56 ± 25 yr, 7 females) were studied to determine whether imposing resistance to the anterosuperior excursion of the hyolaryngeal complex induces fatigue manifested as reduction in pharyngeal contractile pressure during repeated swallowing. Analysis of the video recordings showed significant decrease in maximum deglutitive superior laryngeal excursion and UES opening diameter (P
Swallow strength training exercise for elderly: A health maintenance need. [2019]Recent studies have shown high prevalence of oropharyngeal dysphagia associated with frailty- and age-related muscle weakness. Strength training exercises have been advocated for locomotive health maintenance in the elderly and have shown positive outcomes. As muscles involved in oropharyngeal phase of swallowing are also comprised of striated muscles, the aim of this study was to determine biomechanical effect of a novel resistance exercise program, Swallowing Against Laryngeal Restriction (SALR), on pharyngeal phase swallowing in the healthy elderly.
How a personalised transportable folding device for seating impacts dysphagia. [2023]A personalised transportable folding device for seating (DATP) on a standard seat was developed by an occupational therapist at the Toulouse University Hospital Centre (patent no. WO 2011121249 A1) based on the hypothesis that the use of a seat to assist with better positioning on any chair during meals modifies the sitting posture and has an impact on cervical statics which increases the amplitude of movements of the axial skeleton (larynx and hyoid bone) and benefits swallowing. The aim of this work is to demonstrate that an improvement in sitting posture with the help of the DATP, through Hyoid bone motion, has an impact on the quality of swallowing in a dysphagic population which benefits from the device in comparison to a dysphagic population which does not benefit from the device after 1 month of care. The secondary endpoints concern the evaluation of the impact on other characteristics of swallowing, posture, the acceptability of the device and the quality of life.
Standardized instrument for lingual pressure measurement. [2018]Disease-related atrophy of the tongue muscles can lead to diminished lingual strength and swallowing difficulties. The devastating physical and social consequences resulting from this condition of oropharyngeal dysphagia have prompted investigators to study the effects of tongue exercise in improving lingual strength. We developed the Madison Oral Strengthening Therapeutic (MOST) device, which provides replicable mouth placement, portability, affordability, and a simple user interface. Our study (1) compared the MOST to the Iowa Oral Performance Instrument (IOPI), a commercial pressure-measuring device, and (2) identified the optimal tongue pressure sampling rate for isometric exercises. While initial use of the MOST is focused on evaluating and treating swallowing problems, it is anticipated that its greatest impact will be the prevention of lingual muscle mass and related strength diminishment, which occurs even in the exponentially increasing population of healthy aging adults.
Effects of oral exercise on tongue pressure in Taiwanese older adults in community day care centers. [2022]Oral exercise is a training method for swallowing dysfunction in older adults. The study investigated the effect of oral exercise on tongue pressure in older adults in Taiwanese community day care centers over a 3-month period.
The Effects of Different Exercise Trainings on Suprahyoid Muscle Activation, Tongue Pressure Force and Dysphagia Limit in Healthy Subjects. [2021]Suprahyoid muscle activation and tongue pressure force play a critical role for swallowing function. In addition, dysphagia limit is one of most important factors indicating swallowing efficiency. The purpose of this study was to compare the effects of 8-week training sessions of three different exercises including chin tuck against resistance (CTAR), Shaker exercises and chin tuck exercise with theraband on suprahyoid muscle activity, anterior tongue pressure and dysphagia limit in healthy subjects. Thirty-six healthy volunteers aged between 18 and 40 years who scored below 3 points from Turkish version of Eating Assessment Tool (T-EAT-10) were included in the study, and all participants were divided into three groups randomly. Maximal suprahyoid muscle activations and dysphagia limit of participants were assessed by superficial electromyography. CTAR and chin tuck exercise with theraband increased the maximum suprahyoid muscle activation (p1 = 0.004, p2 = 0.018), whereas Shaker exercise did not increase maximal suprahyoid muscle activation (p = 0.507) after exercise training. CTAR and chin tuck exercise with theraband increased tongue pressure (p1 = 0.045, p2 = 0.041), while Shaker exercise did not increase anterior tongue pressure (p = 0.248). There was no statistically significant difference in dysphagia limits in three groups between before and after exercise training (p > 0.05). As a result, although CTAR seems to be the most effective exercise in most parameters, chin tuck exercise with theraband can also be used as an alternative to CTAR to improve suprahyoid muscle activity and tongue pressure.