Hello, my name is Leah Thomas, and today I'll be talking you through the results of a clinical study using the LymphaVibe.
A novel wearable device for lymphedema management. Imagine you're a breast cancer survivor.
Who just completed chemotherapy only to find your arm beginning to swell and feeling unbearably heavy.
You're not alone. Around 40% of breast cancer patients develop lymphedema.
A chronic and incurable condition. And it's not limited to just breast cancer.
Globally, there's over 140 to 200 million people that are affected.
The current treatment options, such as manual lymphatic drainage. Or pneumatic compression devices are often uncomfortable, limit room.
Limit mobility and they have poor patient adherence. As you can see in this image, the standard pneumatic pump restricts movement and is extremely bulky.
To address these issues, my team and I developed the LymphaVibe.
A wearable sleeve with embedded motors that deliver customizable vibration patterns mimicking manual lymphatic drainage.
Our goal was to create a solution that enhances comfort, mobility, and adherence.
Adherence is critical for effective lymphedema treatment. From literature reviews and customer discovery, we learned that device comfort, usability, and even the perceived benefit of a device are key factors of long-term device use.
Many existing devices fail to meet these needs, leading to preventable barriers and suboptimal outcomes.
That's why our approach is grounded in patient-centered design involving users throughout the design process.
To improve their satisfaction, adherence, and the clinical results. This study brings the patient's voice to the forefront By evaluating LymphaVibe's comfort, usability, and therapeutic effectiveness through patient-centered and usability frameworks.
In the upper left corner, you can see the LymphaVibe use.
It's a flexible sleeve secured with Velcro straps and it houses 16 motors wired in pairs to stimulate both the back and front of the arm.
Each motor is embedded in a silicone pod to better distribute the vibration.
This was an IRB approved, self-controlled prospective cohort study. 15 participants with upper extremity lymphedema received weekly vibration treatments for four weeks in addition to their standard care.
Our study methodology consisted of first marking the affected arm at the wrist palm trees and every 10 centimeters of the arm.
Recording the circumference of the arm, the lymphedema life impact scale scores, which I'll refer to as LLIS, and the physical symptoms of the patient.
Then each patient had a 36-minute vibration treatment with the LymphaVibe.
The measurements and scores were recorded again immediately after that treatment and once more after receiving standard decongestive therapy from a trained therapist.
Each patient was then contacted by phone to complete a post-trial survey.
Our quantitative analysis included paired t-tests for circumference changes. Wilcoxon signed rank tests for the LLIS scores and descriptive statistics for two Likert scale questions on comfort and effectiveness.
Our qualitative analysis came from a mixed method usability survey, which we developed with clinician input and was grounded in human factors literature And the system usability scale.
There were 10 open-ended questions exploring patient experiences And they were assessed through thematic analysis.
Twelve participants completed the usability survey. Patients reported effective swelling reduction, comfort and ease of use, and portability.
As positives. Some criticisms included limited sizing options, difficulty donning the device independently.
And short-lived symptom relief. From the Likert questions, the patients rated the device comfort at an 8.4 out of 10, and the therapeutic effectiveness at 7.5 out of 10.
These perceptions were supported by our clinical data. We found statistically significant reductions in arm circumference at the 30 centimeter and 40 centimeter positions on the arm.
The LLIS scores dropped by an average of 2.3 points, indicating meaningful improvement in physical symptoms.
In conclusion, 83% of our patients said that they would recommend LymphaVibe to others.
The study suggests that the device is safe and it addresses key patient needs through improved comfort and a slimmer design.
We also found that the LymphaVibe combined with manual therapy had positive therapeutic benefits.
Our limitations included a small sample size. With 15 participants and 12 surveyed.
Which is appropriate for a phase one trial, but still limited.
There was potential recall bias, which might have influenced survey responses.
And while each patient received individualized standard therapy post-treatment. The LymphaVibe protocol was uniform for each patient.
For our future research, we plan to modify the device and treatment protocol to prolong the therapeutic effects and to assess how personalized vibration settings could benefit each patient.
We will also design a broader range of sizing options and we plan to conduct long-term clinical evaluations in a larger, more diverse patient population.
Thank you.