Study of the Guardian System on Motor Recovery and Impact on Length of Stay in Ischemic Stroke Patients

This clinical research study is a prospective, non-blinded randomized clinical trial. The
study protocol and consent form have been approved by the IRB at the Study Institution. As
per the study design, consecutive adult patients admitted to the neuro-intensive care unit,
with acute ischemic stroke, meeting the inclusion and exclusion criteria will be consented
and enrolled in the study. Both the Study and Control groups will receive the standard of
care for ischemic stroke according to the hospitals' protocols, policies and procedures.
After obtaining informed consent, patients in the study arm will have the non-invasive
perfusion enhancement system (The Guardian System) placed on their beds and chairs. The
inflatable surfaces (the enhancers) will be placed directly on the mattress and chair under
the fitted sheet and bed linens. They will be secured with a non-porous, non-slip silicone
attacher. An adaptive pressure controller will be attached to the perfusion enhancer through
a connector set. The adaptive pressure controller will be secured to the bed foot board or
side rail and have the ability to be secured to an Intravenous pole as necessary. Specific
data points for each patient in the Experimental group will be entered into the Controller:
they include the patient's weight in kilograms and the patient's position (bed or chair).

This study seeks to evaluate the device's effect on motor recovery and length of stay in a
homogeneous ischemic stroke population that will be randomized for use of the novel
non-invasive perfusion enhancement device from admission to discharge.

Inclusion Criteria:

- Only Acute Ischemic Stroke Patients

- Baseline Modified Rankin Score of less than or equal to 0-2

- Remains hemiplegic (left or right) with motor component score on National Institute of
Stroke Health Scale of 2-4 on arm/leg with or without thrombectomy/tissue plasminogen
activator

- Insured (Medicare or private)

Exclusion Criteria:

- Dementia or Alzheimer Diagnosis

- Concurrent hemodialysis

- Obesity with Body Mass Index greater than 33

- Baseline Modified Rankin Score of 3 to 5

- Patients requiring ventilator support of greater than 2 days

- Peripheral neuropathy

- Concurrent deep vein thrombosis or venous thromboembolism

- Presence of concurrent pre-existing pressure injury

- Prolonged inconsistent use of perfusion therapy defined as two or more consecutive
hours off of the perfusion enhancement device