For each study visit, participants will be asked to arrive 45 minutes before the
beginning of their regularly scheduled follow-up visit. Research activities will take 45
minutes.
Upon early arrival to their regularly scheduled appointment, participants will be fitted
for their very own, "athletic sleeve" by a member of the research team. This athletic
sleeve will be used throughout the duration of the study. Participants will be asked to
come wearing a tank top or short-sleeved t-shirt. If they do not come dressed as such,
they will have the opportunity to change in a private space.
Before donning the athletic sleeve, a member of the research team will measure the
participant's upper limb circumference and induration and administer a baseline survey
using the first section of the Lymphedema Life Impact Scale (LLIS - document attached).
Upper extremity circumference will be measured in centimeters at several points, which
are: palmar crease, the wrist below the styloid process, wrist + 10 cm, wrist + 20 cm,
wrist + 30 cm, and wrist + 40 cm. Upper extremity induration will be measured at the same
points as circumference. These measurements are being taken solely for research purposes
and should take approximately 3 minutes.
The athletic sleeve will be donned by the participant and the novel therapeutic device
will be placed over it. A standardized sequence of vibratory therapy will be applied. Use
of this device will not impact standard of care in any way. The participant may ask to
stop the research session at any time
The athletic sleeve will then be removed, and a member of the research team will measure
the participant's upper limb circumference and induration and administer a survey using
the first section of the Lymphedema Life Impact Scale. These measurements are being taken
solely for research purposes and should take approximately 3 minutes. Participants will
be asked if they experienced any side effects or adverse effects.
Standardized decongestive therapy will be performed by qualified personnel. This step
takes approximately 1 hour and would happen regardless or whether or not patients are
enrolled in this study. At the conclusion of the standardized decongestive therapy, the
measurements and surveys mentioned previously will be repeated. Participants will also be
asked if they experienced any side effects with the standard of care treatment.
This series of steps will be repeated at the participants' weekly follow-up visits for
four weeks. Standardized decongestive therapy for lymphedema is most often performed on a
weekly basis (and is one of the inclusion criteria for this study). Therefore, choosing
this visit frequency would not greatly alter a participant's schedule or ability to
perform other daily tasks.
If a participant chooses to withdraw from the study early or needs to be removed from the
study for their own safety, notes will be added to research documentation and the
patient's electronic medical chart indicating their departure from the study. Going
forward, they would receive standard decongestive therapy as before their participation
in the study.
Study subject limb circumference, induration data, and survey data will be analyzed using
a paired t-test.