[Editors note: This article is about an innovative device and complimentary therapy currently under clinical trial evaluation. NFOSD’s intent in publishing this material is to alert the dysphagia community about “potential” advances in dysphagia treatment options; it is not a product or therapy endorsement. Following exposure to this device and therapy at the Dysphagia Research Society (DRS) conference in mid-March 2013, NFOSD initiated contact with Dr. Robbins. We’d like to thank her and her team for providing this information to us and our community.]
Pictured Above: Dr. Robbins with MOST® device and patient
Q: What is the MOST device?
The Madison Oral Strengthening Therapeutic (MOST®) device is based on pioneering research taking place at the University of Wisconsin and the Wm. S. Middleton Memorial Veterans Hospital, in Madison, WI, by a team of clinicians and researchers in the field of swallowing / dysphagia under the direction of Dr. JoAnne Robbins. Their work has demonstrated that the active rehabilitation of swallowing musculature improves swallowing safety and eating enjoyment. The MOST® device performs a dual role of 1) identifying risk for dysphagia through screening by assessing tongue muscle strength and 2) providing therapy by facilitating Isometric Progressive Resistance Oropharyngeal (I-PRO) strengthening of the tongue and related muscles.
The MOST® device comprises a multi-sensor, custom molded mouthpiece and user-friendly software allowing therapy to be tailored to each patient’s specific needs. As the patient becomes stronger, new goals are created to progress the patient to even greater swallowing advancements. The user-friendly software provides immediate information to the patient about therapy performance, resulting in strengthened swallowing and allowing him/her to make adjustments for greater success. The MOST® device records all therapeutic interventions completed by the patient and provides a printable report detailing patient performance.
Q: What is the thinking (or science) behind the MOST device and how did it evolve into its current state?
Muscles weaken as an aspect of aging (sarcopenia), even healthy aging; this includes muscles of the head and neck. Less healthy people, for instance those who suffer a neurologic disorder such as stroke, dementia or Parkinson’s, have had a head injury or head and neck cancer, have increased muscle weakness beyond that of normal aging. I-PRO therapy for improved swallowing function has been shown by several respected clinician / researcher Speech Language Pathologists from leading academic institutions (Refs 1-5) to be therapeutically effective. Research in patients performing the therapy demonstrated reduced aspiration (material entering the airway) with liquids and less oropharyngeal post-swallow residue.
There are a number of available therapies out there for people who suffer from dysphagia. Some of them are postural, such as turning the head to the side of the weakness to propel food or liquid down the stronger functioning side, or require dietary modification such as adding a thickening agent to all fluids that a patient drinks. The MOST® I-PRO approach is relatively unique in that it facilitates active rehabilitation of the muscles of swallowing NOT while eating. In other words, the approach is not merely compensating for deficits and needing to be implemented DURING eating on every swallow, such as postural or food adjustments, but it is performed at other times (non-eating times) during the day so that meal enjoyment is optimized by eating naturally with increased strength and coordination.
Q: This device is used in conjunction with an I-PRO therapy program. Please describe how an individualized program is developed.
After the patient’s mouthpiece has been custom-molded to the roof of the mouth, which takes about 10 minutes, the next step is to determine the patient’s baseline tongue strength. This is done by having the patient press his/her tongue with maximal effort against the mouthpiece sensors. Knowledge of the baseline performance allows the clinician to identify attainable yet challenging therapy goals (usually 60% – 80% of the one repetition maximum) as well as provides a quantifiable reference for reporting outcome data. Every two weeks, maximum tongue pressures are re-measured so that new customized therapeutic targets can be identified as the patient becomes stronger.
Q: Please describe what a typical I-PRO therapy program might look like (e.g., number of times per day over how many weeks)?
The MOST® facilitated I-PRO regimen is evidence-designed and based on Sports Medicine research. A typical therapy regimen requires 10 tongue press repetitions at each identified sensor, three times per day on three days per week for eight weeks. Re-evaluation of swallowing function, often using videofluoroscopy (moving x-ray recording while patient swallows) is recommended at 4 and/or 8 weeks to assess swallowing improvement that accompanies stronger and more coordinated musculature and function.
Q: What swallowing attributes or characteristics do you look for in a patient who would most benefit from this therapy?
Patients for whom MOST®-facilitated I-PRO therapy is indicated are those with significant post-swallow residue (stasis of food or liquid) in the mouth or throat, misdirection of food or liquid into the airway (aspiration) or “deep” penetration of the laryngeal vestibule, poor control or propulsion of food or liquid through the mouth and throat and/or incomplete / reduced opening of the top of the esophagus (upper esophageal sphincter / UES).
Q: How are an individual’s attributes assessed with respect to being a good candidate for this therapy (i.e., what tests and tools are used in this assessment process)?
The first step in assessing candidacy for MOST®-facilitated I-PRO therapy is completion of an instrumental assessment such as a videofluoroscopic swallowing evaluation (moving x-ray while patient is swallowing). This is usually completed by a Speech Language Pathologist and Radiologist team. The second step is using the MOST® device to identify below-normal pressure generation. It is the combination of reduced pressure generation by the tongue and limited, unsafe movement of food / liquid through the mouth and throat that makes a patient an ideal candidate for I-PRO therapy.
Q: How does one objectively measure the success of this therapy at an individual level?
The MOST® device documents objective pressure readings throughout the therapy process allowing the patient and clinician to monitor progress. Functional improvements of increased oral intake, new foods included in the diet, weight gain, reduced aspiration of food and liquid into the airway and improved quality of life also are critical measures of success.
Q: This device and therapy are currently part of a clinical trial (NCT01570023). Can you talk about the size of the trial, current enrollment, inclusion and exclusion criteria and any initial trial results?
This study is a multi-site, randomized clinical trial to determine the effectiveness of the 8-week I-PRO regimen performed by patients with dysphagia, compared to a control group of patients with swallowing problems who do not complete I-PRO therapy, but receive standard clinical care. One hundred male and female patients will take part in this study from eight participating facilities around the country. No preliminary results from this trial are yet reported, however it is well underway and 25 subjects/patients have successfully completed the intervention to date.
Inclusion Criteria: referral by a physician for swallowing evaluation because of suspected dysphagia; complaint of difficulty swallowing; aspiration or penetration of the airway with liquids or semisolids OR post-swallow residue visible in the mouth or throat; 21-95 years of age; ability to perform the therapy protocol independently or with the assistance of a caregiver; physician approval of medical stability to participate and decision-making capacity to provide informed consent.
Exclusion Criteria: degenerative neuromuscular disease; poorly controlled psychosis; inability to complete the therapy program; allergy to barium (used in videofluoroscopic swallowing assessment).
Madison Oral Strengthening Therapeutic (MOST®) device
For more information about the study, call The UW/VA SWALlowing Speech And Dining Enhancement (SSWAL-ADE) Program at (608) 256-1901 ext. 11125.
References
1. Malandraki GA et al., The effects of lingual intervention in a patient with inclusion body myositis and Sjögren’s syndrome: a longitudinal case study. J Arch Phys Med Rehabil. 93(8):1469-75; Aug 2012
2. Robbins J et al., The Effects of Lingual Exercise in Stroke Patients with Dysphagia. Archives of Phy Med and Rehabilitation 88:150-158, 2007.
3. Lazarus, C. Tongue Strength and Exercise in Healthy Individuals and in Head and Neck Cancer Patients. Sem of Speech Lang Path 27:260-267, 2006.
4. Robbins J et al., The Effects of Lingual Exercise on Swallowing in Older Adults. J Amer Geriatrics Society 53:1483-1489, 2005.
5. Clark H et al., Effects of Directional Exercise on Lingual Strength. J of Sp Lang and Hearing Res 52:1034-1047, 2009