Clinical trial shows improvement in stroke patients using Constant Therapy program

At Constant Therapy Health, we’re committed to providing evidence-based, clinically proven and effective products to our patients and clinicians. As part of this commitment, in 2019 we ran the first fully decentralized controlled clinical research study on aphasia, loss of language after stroke, to confirm the efficacy of the Constant Therapy program. The results confirmed and exceeded our expectations! We were thrilled to have our paper accepted for publication in the peer-reviewed journal, Frontiers in Neurology, and to be selected to present at the American Congress of Rehabilitation Medicine’s annual conference in October 2020, and we’re excited to share the results with you now. 

Background

When we set out to do this study, we didn’t want to limit ourselves by only recruiting patients from our home base of Boston, Massachusetts. And because technology has made our world smaller, we decided to make the most of that. So, we embarked upon one of the first completely virtual clinical trial for patients with aphasia, loss of language after a stroke. We invited people with aphasia from the United States and Canada who were no longer receiving direct speech and language therapy to participate in the study. It was our aim to learn whether the Constant Therapy Program could help people not currently in therapy still improve their speech, language, and cognitive skills, while filling the gap for those who no longer had access to in-person therapy. 

Creating a patient-centric experience

We began the trial with the intention of developing an excellent experience for all participants. This vision drove every decision we made over the course of the study. To begin with, we sent all participants a tablet device with pre-installed video conferencing software and the tools to complete the assessments that we’d be using to track their progress. We then met with participants and their caregiver over video chat to explain the study to them and walk through the consent forms that we had mailed them. Next, we completed our assessment set (more on that below), and once the assessments were complete, we assigned participants randomly to either the experimental or the control group (more about the groups in a moment), while balancing to make sure that the assessment scores between the two groups were comparable. We conducted the entire study process over video conference, allowing the participant and their caregiver to take part entirely from the comfort of their own home.

Study Design

Assessments

When deciding on efficacy measures, we carefully chose assessments already validated for remote administration, meaning scientists already made sure that scores on these tests were not statistically different whether they were given remotely or in person. We used the following assessment tools:

• The Western Aphasia Battery, Revised (WAB-R) – this assessment looks at speech, language, and cognitive skills for people with aphasia. We completed the full assessment, which looks at spontaneous speech, auditory comprehension, naming, repetition, reading, writing, apraxia, and visuospatial skills.
• The Brief Test of Adult Cognition by Telephone (BTACT) – this is a quick assessment specially designed for remote administration that evaluates memory for and reasoning with words and numbers.
• The Stroke and Aphasia Quality of Life Scale 39 (SAQOL-39) – this is a questionnaire that either participants or their caregivers completed to quantify the impact of a stroke on daily activities, communication, emotions, and family and social life. Once participants completed their 10 weeks of treatment, we gave these same assessments again to measure their progress.

Treatment Groups

In order to understand the impact of the Constant Therapy program, we assigned participants to two different groups, an experimental group and a control group, to allow us to compare their results at the end of the study. Typically, the experimental group receives the treatment being tested, while the control group receives whatever the current standard of care is (standard of care refers to the treatment most commonly used today). Here were the group assignments:

• Experimental Group – the experimental group used a custom version of our commercially available program, Constant Therapy. They were encouraged to practice with the program on their tablet device at least 5 days a week, and they were assigned a starting set of exercises based on their scores during the initial assessments. Following that, our NeuroPerformance Engine™ (NPE) took over, and provided tasks to patients that were harder or easier based on how accurately and how quickly they completed previous therapy tasks.
• Control Group – the control group completed speech pathology workbook pages, which is currently the standard of care — a typical treatment that someone who was no longer participating in speech therapy might complete. If we heard that the workbooks were too easy or hard, or if the participant finished a workbook, we sent them another one. Participants were also encouraged to practice at least 5 days a week.

Check-ins

Every 2 weeks, study staff checked in with participants in both the control and experimental groups to see how their therapy was going. We asked participants and their caregivers what had been easy and what had been difficult about their practice over the previous two weeks and reminded them to continue practicing going forward. After patients completed their final assessments, participants in both groups were able to use Constant Therapy on the tablets we sent them as a token of our appreciation for participating in the study.

Results using the Constant Therapy program

And now what you’ve all been waiting for… the numbers! It was important to us to look beyond just statistical significance (though we of course did that as well). We also wanted to look at clinical significance, or how much improvement we needed to see from participants for there to be a marked, observable, clinical difference in their speech, language, and cognitive skills relative to their initial assessment results. Based on previous studies, we knew that “magic number” for clinical significance was at least 5 points of improvement on the WAB-R’s Aphasia Quotient (AQ) score, which gives an overall score of aphasia severity.

Additionally, we saw improvements from both the control and experimental groups on the portion of the quality of life scale, the SAQOL-39, that assesses communication. We also took a look to see if there was a correlation between time since stroke and improvement on the WAB-R AQ score – and there was not. On average, the experimental group improved an average of 6.75 points on the WAB-R’s AQ, while the control group improved an average of 0.38 points on the WAB-R’s AQ. Even when we controlled for possible factors differing between the experimental and control groups, such as age, time since stroke, and their original WAB-R AQ scores (none of these were statistically significant to begin with), the experimental group still made an average improvement of 6.64 points. This improvement was statistically significant at the 1% level AND was above that clinical significance number of 5!

The real-world impact of all of this? Well, that has to be seen to be believed. Check out these incredible before and after videos of some of the study participants.

So, what does it all mean? Here are some takeaways

• Participants using our tablet-based therapy app made statistically and clinically significant gains in their skills.
• People with aphasia can continue to make huge gains and progress no matter how much time has passed since their stroke. Time and again, the science proves that the 1- year recovery window is a myth.
• All participants found quality-of-life benefits from participating in the study – we hypothesize this is because they had the opportunity to take control, and actively work on their recovery, while receiving encouragement and accountability check-ins from staff.
• We completed this study before COVID-19 changed our world and forced us at a rapid pace towards more virtual therapy options, and it turns out that this study could not have been more timely. All of our check-ins were done virtually, and participants consistently attended those sessions and received quality-of-life benefits from participating in the study. 
• Finally, this study proves that patients with aphasia and caregivers can successfully participate in a virtual study. Participants did a fantastic job of navigating the technology, and the caregivers were essential, acting as our camera women and men, all while being careful not to prompt their loved ones so that they did not impact the assessment scores.

Our founding scientist, and the overseer of this study, Dr. Swathi Kiran of Boston University, summed it up perfectly: 

“The results of this study are not only incredibly encouraging for people with post-stroke communication disorders, it’s also a monumentally important example of the role that teletherapy has, and will continue to play, in healthcare going forward. This study opens up a whole new paradigm for how we structure clinical trials, and who can participate.”

Our heartfelt thanks

We want to take this time to send a HUGE thank you to the participants and their caregivers who participated in our study, including those who didn’t qualify for the study but participated in our screening process. We are so thankful for your time and encouraged by your dedication to your recovery. You inspire us each and every day, and we are eternally grateful.

Check out the peer-reviewed publication with the full details and results of this study here!