All the patients will be reviewed for inclusion and exclusion of the study in detailed manner using medical evaluation form. The physical examination part of the medical evaluation form will be filled out by one of our designated physician investigators. A urine pregnancy test will be administered if necessary at this time.
The patient's neck physical dimensions and device's physical dimensions will be measured and recorded using the Biometric form.
A baseline functional outcome assessment of swallowing (FOAMS) will be performed for each patient.
Patients will be sitting in an upright position with the head held in neutral position at Fluoroscopy lab and acclimatized for 10 minutes before proceeding.
Patient's anatomic structure and landmarks are identified in both lateral and anteroposterior (AP) views with fluoroscopy.
A 4 mm diameter catheter with 3 markers 3 cm apart will be placed on the skin in the pharyngo-UES region for the purpose of calibration and nullify the error from magnification during videorecording.
Patient will be asked to swallow barium suspension at incremental volumes of 1, 3 and 5 ml; however, if the patient develops aspiration or doesn't tolerate barium suspension higher volumes will not be administered. Following are test swallows under fluoroscopy:
1 ml- 40% weight/volume barium suspension at room temperature x 3 times each. 3 ml- 40% weight/volume barium suspension at room temperature x 3 times each. 5 ml- 40% weight/volume barium suspension at room temperature x 3 times each. The fluoroscopy machine will be turned "on" for 5 seconds ONLY during each swallow. Rest of the time fluoroscopy machine will be turned "off".
Fluoroscopic recordings were obtained at 90 kilo-electron-volt (KeV), using a 9-inch image-intensifier mode and appropriate collimation so that an image was obtained of the posterior mouth, pharynx, and pharyngoesophageal region. Fluoroscopic recordings will be timed using a specially designed timer.
After the baseline fluoroscopic study, each patient will be randomized to receive either the sham exerciser (i.e. device with no pressure) or pharyngeal exerciser (i.e. device with graded pressure).
Study Groups:
Pharyngeal exerciser group: In this group, the device will be placed around the neck overlying the laryngeal cartilage. The device will be in contact with the skin without any underlying pressure using the Velcro fastening in the back of neck. The externally applied pressure will be measured by means of the pressure gauge included in the device (see figure). Patients are asked to follow exercise regimen: to perform 30 swallows at 15 seconds interval against minimal resistance of 20 mm Hg applied by pharyngeal exerciser over larynx during the first 2 weeks. This is repeated 3 times per day and the external resistance is increased every 2 weeks from 20 to 30 mm Hg and subsequently from 30 to 40 mm Hg in another 2 weeks.
Sham exerciser group: In this group, sham device will be placed around the neck overlying the laryngeal cartilage. No external pressure will be applied during exercise. These patients will be asked to follow the exercise regimen: to perform repetitive tongue protrusion for 5 times without any pressure. This will be repeated 3 times a day for 6 weeks.
All the exercise instructions and log record will be given to each of the patient in both study groups at the time of randomization. The exerciser (sham or pharyngeal) will be worn only at the time of exercises.
Weekly telephone interviews will be conducted to assess their progress and address their concerns in both study groups.
Patients in both study groups are required to make follow up visits every 2 weeks. During the follow up visits, patients will be reviewed for symptom severity and resistance of the device. This information is documented in patient progress sheet and follow up visit form. All the adverse events during the study or from the device will be documented in the adverse and serious adverse events form. The compliance with the device will be evaluated by examining the exercise log sheet.
After 6 weeks, the device (sham exerciser or pharyngeal exerciser) will be returned to the study team and patients will be asked to complete functional outcome assessment of swallowing (FOAMS).
Each patient will undergo follow up fluoroscopic study with the same test swallows as the baseline swallows, looking for pharyngeal residue and aspiration (repeat steps: 4 to 9).
All the fluoroscopic images will be recorded and stored in digitalized format at 30 frames (60 fields/second) in a secure location at the research lab (locked in safe location and accessible only to the investigators). These the fluoroscopic studies will be analyzed for the study parameters as mentioned below by two individuals in a blinded fashion.
At the end of study period, each of the patients in sham group will be given an option to undergo another 6 weeks of pharyngeal exercise using pharyngeal exerciser. If they consent again(using informed consent form) to participate, they would be following above exercise protocol(30 swallows against 20 mm Hg of resistance with pharyngeal exerciser three times a day for 2 weeks; followed by swallowing exercise with incremental resistance of 30 and 40 mm Hg for 2 weeks each). At of 6 weeks, they would undergo repeat fluoroscopy study to check for improvement in pharyngeal residue (repeat steps: 4 to 9).
The participants will be followed after completion of the exercise regimen for a total of 12 months. At 3 months after the completion of initial exercise study, the participant will be contacted and informed about the follow up portion of the study. If they are in agreement, the participant will be asked to come to the lab to be reconsented and complete an EAT-10 form. At this time, the participant will be asked questions such as current diet consistency, evidence of cough with eating, additional time needed during meals, etc to determine FOAMS score. The patient will only be interviewed after consent is obtained. At 6 months, the subjects will undergo repeat fluoroscopy for an objective measure of their swallowing. At this visit they will also be asked to complete an EAT-10 form and a FOAMS score will again be determined. At 12 months, the participant will not be required to return to the lab. They will also be mailed a swallowing assessment form (EAT-10) to be filled out and returned at 12 months (subjects will be asked to complete the paper form for consistency). The participant will also be contacted for a telephone interview to be asked questions such as current diet consistency, evidence of cough with eating, additional time needed during meals, etc to determine FOAMS score. For those subjects who are newly enrolled, re-consent will not occur since there is only one consent form which includes the follow-up information. Newly enrolled subjects will be presented with the follow-up information at the time of initial consent.
During the entire study period, the participant will be instructed to continue their standard of medical care (medications, diet, physical therapy and activity) as suggested by their personnel physician.
All the fluoroscopic studies will be analyzed by two individuals in a blinded fashion.
After the completion of the study, individuals in the sham exerciser group will be given the option of doing exercises using pharyngeal exerciser. If they are interested, consent will be obtained using new consent form before re-enrolling into the study.
