Gabriela Constantinescu, speech-language pathologist and chief technical officer of True Angle, helps Leslie O'Connor-Parsons, head and neck cancer patient and participant in the clinical trial, attach the Mobili-T device to measure her swallowing exercises.
(Edmonton) This past Thanksgiving, Leslie O'Connor-Parsons enjoyed a full meal with turkey and stuffing for the first time in five years. Diagnosed with head and neck cancer in 2014, O'Connor-Parsons had been on a liquid food diet consisting of runny blended soups, shakes or smoothies until recently because she had difficulty swallowing.
"When I first left the hospital after my surgery, I was supposed to practice swallowing. I wanted to swallow something-coffee, water. But I developed a fear of food. I live alone and was terrified of choking or aspiration pneumonia," she said. "I was proud when I was able to switch from a feeding tube in my stomach to liquid nutrition by mouth, but I was so committed to never eating a regular meal again that when I moved, I got rid of my kitchen table and chairs."
Thanks to Mobili-T, the first mobile home-based swallowing therapy device, O'Connor can slowly enjoy meals now, including Thanksgiving dinner and one of her favourites: a burger with cheese and mustard.
O'Connor-Parsons was one of 20 participants with head and neck cancer that participated in a University of Alberta feasibility trial for Mobili-T, which assists patients with swallowing disorders to re-train throat muscles to swallow. Preliminary findings from patient-reported outcomes of the trial showed that 25 per cent of the patients had clinically important improvements following six weeks of using the Mobili-T device. The patient reports also shined a light on the daily challenges of dysphagia, as many reported an overall increased hope and quality of life.
Mobili-T is a wireless piece of hardware that senses muscle activity when it is placed under the chin. It gives patients direct feedback about swallowing muscle activation. An app that provides real-time biofeedback on a mobile device leads patients through swallowing therapy. The app also provides a direct connection to a prescribing clinician, who can for the first time ever, reliably track patient progress and adherence.
"The ability to eat normally can be destroyed by medical conditions such as head and neck cancer, stroke, traumatic brain injury and neurological disorders such as Parkinson's, amyotrophic lateral sclerosis (ALS) and multiple sclerosis. Swallowing disorders (also known as dysphagia) affect as many as two in 10 adults over the age of 50, approximately 20 million people in the U.S. and over 250 million people worldwide," said Jana Rieger, co-founder of True Angle Medical Technologies Inc., the spin-off company that developed the Mobili-T device, and professor in the Faculty of Rehabilitation Medicine, University of Alberta.
True Angle was co-founded by Rieger, chief executive officer of True Angle, Dylan Scott, an alumnus of the Faculty of Engineering ('06 BSc MechE) and chief technical officer of True Angle, and Gabriela Constantinescu, an alumnus of the Faculty of Rehabilitation Medicine ('08 MSc SLP, '18 PhD) and chief product officer of True Angle.
"Swallowing impairments often result in dire consequences, including choking or suffocating when food goes down the wrong way, aspiration pneumonia when food or liquid enter the lungs, and starvation, weight loss and muscle wasting from the inability to safely consume enough food," said Rieger, who is also a U of A researcher and director of research at the Institute for Reconstructive Sciences in Medicine (iRSM). "Patients often have to eat blended food and drink liquid food products or resort to tube feeding. This can all lead to depression because alterations in eating affect social interaction and destroy overall quality of life."
Research has demonstrated that intensive swallowing therapy, particularly therapy that provides patients with biofeedback regarding muscle activity, can improve oral intake, reduce aspiration and eliminate the need for feeding tubes in many patients, explained Rieger. But current biofeedback systems rely on very large pieces of equipment that are clinic-based, meaning patients have to regularly visit a clinic for intensive therapy sessions. This inconvenience means many patients simply don't get the therapy that they need.
The feasibility trial for Mobili-T showed that patients may soon have a better, more flexible and mobile alternative.
"The 20 participants took the system home and were able to complete treatment using the technology. We completed a pre-treatment and a post-treatment assessment, but throughout the trial, we also looked at how adherent patient participants were to what we prescribed. Adherence data from this trial are really important because in our field no one has looked at objective adherence to home-based therapies in this way; the use of self-report is the typical approach to learning what patients do at home," said Constantinescu.
"We found that from week one to week six, the average adherence stayed really high. For week one, 84 per cent of the prescribed exercises were getting done and in week six, about 72 per cent," she said. "We're excited about that because these adherence rates were higher than those currently reported in the literature for home-based dysphagia therapy without biofeedback (21.9 to 51.9 per cent)."
The team also found that patients became more interested in food and that it would take less time to finish a meal. It helped them want to try more new foods and become more hopeful about their situation.
"Two weeks after I finished participating in the study, I was still only able to swallow liquid food. So when I was able to eat a burger, I couldn't believe it-I can actually eat a burger now!" said O'Connor-Parsons. "It gives you some power back. More than a feeling of accomplishment or control… it gives you back a sense of self."
Up next for True Angle is a usability trial with the Glenrose Rehabilitation Hospital working with stroke patients, which they are currently recruiting participants for. The trial aims to determine whether patients with a stroke can use the system. That trial will be followed by a feasibility trial where patients with a history of stroke are sent home with the system to use.
"When I first left the hospital after my surgery, I was supposed to practice swallowing. I wanted to swallow something-coffee, water. But I developed a fear of food. I live alone and was terrified of choking or aspiration pneumonia," she said. "I was proud when I was able to switch from a feeding tube in my stomach to liquid nutrition by mouth, but I was so committed to never eating a regular meal again that when I moved, I got rid of my kitchen table and chairs."
Thanks to Mobili-T, the first mobile home-based swallowing therapy device, O'Connor can slowly enjoy meals now, including Thanksgiving dinner and one of her favourites: a burger with cheese and mustard.
O'Connor-Parsons was one of 20 participants with head and neck cancer that participated in a University of Alberta feasibility trial for Mobili-T, which assists patients with swallowing disorders to re-train throat muscles to swallow. Preliminary findings from patient-reported outcomes of the trial showed that 25 per cent of the patients had clinically important improvements following six weeks of using the Mobili-T device. The patient reports also shined a light on the daily challenges of dysphagia, as many reported an overall increased hope and quality of life.
Mobili-T is a wireless piece of hardware that senses muscle activity when it is placed under the chin. It gives patients direct feedback about swallowing muscle activation. An app that provides real-time biofeedback on a mobile device leads patients through swallowing therapy. The app also provides a direct connection to a prescribing clinician, who can for the first time ever, reliably track patient progress and adherence.
"The ability to eat normally can be destroyed by medical conditions such as head and neck cancer, stroke, traumatic brain injury and neurological disorders such as Parkinson's, amyotrophic lateral sclerosis (ALS) and multiple sclerosis. Swallowing disorders (also known as dysphagia) affect as many as two in 10 adults over the age of 50, approximately 20 million people in the U.S. and over 250 million people worldwide," said Jana Rieger, co-founder of True Angle Medical Technologies Inc., the spin-off company that developed the Mobili-T device, and professor in the Faculty of Rehabilitation Medicine, University of Alberta.
Leslie O'Connor-Parsons demonstrates the Mobili-T device,
which senses muscle activity when it is placed under the chin
and the paired app that shows her real-time biofeedback and
leads her through swallowing therapy exercises.
"Swallowing impairments often result in dire consequences, including choking or suffocating when food goes down the wrong way, aspiration pneumonia when food or liquid enter the lungs, and starvation, weight loss and muscle wasting from the inability to safely consume enough food," said Rieger, who is also a U of A researcher and director of research at the Institute for Reconstructive Sciences in Medicine (iRSM). "Patients often have to eat blended food and drink liquid food products or resort to tube feeding. This can all lead to depression because alterations in eating affect social interaction and destroy overall quality of life."
Research has demonstrated that intensive swallowing therapy, particularly therapy that provides patients with biofeedback regarding muscle activity, can improve oral intake, reduce aspiration and eliminate the need for feeding tubes in many patients, explained Rieger. But current biofeedback systems rely on very large pieces of equipment that are clinic-based, meaning patients have to regularly visit a clinic for intensive therapy sessions. This inconvenience means many patients simply don't get the therapy that they need.
The feasibility trial for Mobili-T showed that patients may soon have a better, more flexible and mobile alternative.
"The 20 participants took the system home and were able to complete treatment using the technology. We completed a pre-treatment and a post-treatment assessment, but throughout the trial, we also looked at how adherent patient participants were to what we prescribed. Adherence data from this trial are really important because in our field no one has looked at objective adherence to home-based therapies in this way; the use of self-report is the typical approach to learning what patients do at home," said Constantinescu.
The Mobili-T device used in the feasibility trial (left)
and the newest prototype, which is even smaller (right)
and will be stored inside a charging case.
The team also found that patients became more interested in food and that it would take less time to finish a meal. It helped them want to try more new foods and become more hopeful about their situation.
"Two weeks after I finished participating in the study, I was still only able to swallow liquid food. So when I was able to eat a burger, I couldn't believe it-I can actually eat a burger now!" said O'Connor-Parsons. "It gives you some power back. More than a feeling of accomplishment or control… it gives you back a sense of self."
Up next for True Angle is a usability trial with the Glenrose Rehabilitation Hospital working with stroke patients, which they are currently recruiting participants for. The trial aims to determine whether patients with a stroke can use the system. That trial will be followed by a feasibility trial where patients with a history of stroke are sent home with the system to use.