Clinical trial: NCT02564887
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks Of This Study?

Tongue Exercises: You may experience some tongue or jaw soreness as result of the exercises. Adjustment in target pressure value will be made as needed to decrease discomfort. Questionnaires: There may be questions that make you uncomfortable. Please understand that you may skip any questions that you do not wish to answer. Breach of Confidentiality: All records will be maintained in a secured site and / or on password protected computer drives, but just as with the use of your medical information for health care purposes, we cannot guarantee its confidentiality. A copy of this consent will be kept with other study materials in the Department of Otolaryngology.
Clinical trial: NCT02564887
Section: Procedures
Subsections: Group 1: Standard Swallowing Therapy.|Group 2: Standard Swallowing Therapy And Tongue Press Exercises.

Your research participation will consist of two visits, 8 weeks apart that will be conducted at your regular clinical visits. If you are in this group, you will receive standard therapy for your swallowing problems. Standard therapy is the non-research treatment you would receive during regular (non-research) clinical care. Standard therapy is not experimental but the information from your therapy will be used for research purposes. Standard therapy is tailor made to each individual. Your clinicians will take information from your swallowing evaluations to create the best swallowing therapy program for you. This could include changes in your posture, different swallowing techniques such as multiple swallows or something called liquid wash. Changes in your diet may also be a part of the swallowing therapy. The goal of therapy is to increase strength and endurance over the 8 week period. The interventions that were found most helpful on your swallowing exam will be emphasized during these 8 weeks. Crossover Arm: If, at the end of your 8 weeks of standard therapy, you and your clinician determine that you need additional swallowing therapy, you will be given the opportunity to participate in the "crossover arm" of this research. This would involve you undergoing the same therapy program as the individuals in group 2, which involves the additional use of a tongue strengthening device called the Iowa Oral Performance Instrument (IOPI). (please see the detailed description below under "Group 2" and *Tongue Press Exercises and Diary Documentation*) If you participate in the crossover arm, your study participation would include 3 visits in total and your overall participation time would be approximately 16 weeks.

Your research participation will consist of two visits, 8 weeks apart that will be conducted at your regular clinical visits. If you are in this group, you will receive the same standard swallowing therapy that we just described for group 1, but you will also be asked to do tongue press exercises at home during the 8 weeks. The tongue press exercises are considered experimental. All data collected from routine care and the tongue press exercises may be used for research purposes. Tongue Press Exercises *and Diary documentation*: The tongue press exercise consists of pressing a sensor between your tongue and the roof of your mouth. The exercise device is called the Iowa Oral Performance Instrument (IOPI). The IOPI is an FDA registered medical device. This device will measure the amount of "squeeze" between your tongue and the roof of your mouth. The IOPI will indicate when you have hit your target value by displaying green lights. You will press on the sensor with your whole tongue (front and back), reach the target pressure, hold it for 3 seconds, then relax. You will take the IOPI home with you and do 10 repetitions of the exercise, three times a day on three specified days per week for 8 weeks. You will be given an instruction packet to help you to remember which days you are to be performing the exercises. It will take approximately 30 minutes to be trained on how to perform the exercises properly as well as how to record the exercises properly in the diary that will be provided to you. It will take approximately 5–10 minutes to complete 30 repetitions of the exercise.
Clinical trial: NCT02564887
Section: Voluntary Participation
Subsections: Voluntary Consent|Certification Of Informed Consent

All of the above has been explained to me and all of my current questions have been answered. I understand that I am encouraged to ask questions about any aspect of this research study during the course of this study, and that such future questions will be answered by the researchers listed on the first page of this form. Any questions, which I have about my rights as a research participant, will be answered by the Human Subject Protection Advocate of the IRB Office, University of Pittsburgh (1-866-212-2668). By signing this form I consent to participate in this research study and provide my authorization to share my medical records with the research team. ________________________________ __________________ Printed Name of Participant Date ________________________________ Participant's Signature

I certify that I have explained the nature and purpose of this research study to the above-named individual(s), and I have discussed the potential benefits and possible risks of study participation. Any questions the individual(s) have about this study have been answered, and we will always be available to address future questions as they arise. I further certify that no research component of this protocol was begun until after this consent form was signed. __________________________________________ __________________ Signature of Investigator or Person Obtaining Consent Date _______________________________________________ __________________ Printed Name of Investigator or Person Obtaining Consent Role in Research Study