WEBVTT


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Hello, my name is Leah Thomas, and today I'll be talking you through the results of a clinical study using the LymphaVibe.

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A novel wearable device for lymphedema management. Imagine you're a breast cancer survivor.

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Who just completed chemotherapy only to find your arm beginning to swell and feeling unbearably heavy.

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You're not alone. Around 40% of breast cancer patients develop lymphedema.

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A chronic and incurable condition. And it's not limited to just breast cancer.

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Globally, there's over 140 to 200 million people that are affected.

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The current treatment options, such as manual lymphatic drainage. Or pneumatic compression devices are often uncomfortable, limit room.

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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.

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To address these issues, my team and I developed the LymphaVibe.

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A wearable sleeve with embedded motors that deliver customizable vibration patterns mimicking manual lymphatic drainage.

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Our goal was to create a solution that enhances comfort, mobility, and adherence.

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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.

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Many existing devices fail to meet these needs, leading to preventable barriers and suboptimal outcomes.

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That's why our approach is grounded in patient-centered design involving users throughout the design process.

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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.

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In the upper left corner, you can see the LymphaVibe use.

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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.

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Each motor is embedded in a silicone pod to better distribute the vibration.

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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.

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Our study methodology consisted of first marking the affected arm at the wrist palm trees and every 10 centimeters of the arm.

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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.

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Then each patient had a 36-minute vibration treatment with the LymphaVibe.

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The measurements and scores were recorded again immediately after that treatment and once more after receiving standard decongestive therapy from a trained therapist.

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Each patient was then contacted by phone to complete a post-trial survey.

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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.

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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.

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There were 10 open-ended questions exploring patient experiences And they were assessed through thematic analysis.

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Twelve participants completed the usability survey. Patients reported effective swelling reduction, comfort and ease of use, and portability.

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As positives. Some criticisms included limited sizing options, difficulty donning the device independently.

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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.

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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.

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The LLIS scores dropped by an average of 2.3 points, indicating meaningful improvement in physical symptoms.

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In conclusion, 83% of our patients said that they would recommend LymphaVibe to others.

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The study suggests that the device is safe and it addresses key patient needs through improved comfort and a slimmer design.

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We also found that the LymphaVibe combined with manual therapy had positive therapeutic benefits.

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Our limitations included a small sample size. With 15 participants and 12 surveyed.

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Which is appropriate for a phase one trial, but still limited.

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There was potential recall bias, which might have influenced survey responses.

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And while each patient received individualized standard therapy post-treatment. The LymphaVibe protocol was uniform for each patient.

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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.

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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.

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Thank you.