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

Study Overview
=================
Brief Summary
-----------------
This is a non-blinded randomized study that will investigate whether the use of a novel, non-invasive perfusion enhancement system (The Guardian System) impacts motor recovery and hospital length of stay in acute ischemic stroke patients.

Detailed Description
-----------------
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.

Official Title
-----------------
A Randomized, Non-Blinded Clinical Trial of a Non-Invasive Perfusion Enhancement System (Guardian System) on Motor Recovery and Impact on Length of Stay in Mobility Impaired Ischemic Stroke Patients

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Device: Guardian System


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, non-blinded, randomized trial. This cohort will be divided into two groups: (1) The Control Group (2) The Study Group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>The Control Group will receive the standard support surface mattresses/bed surfaces and recovery chairs without the non-invasive perfusion enhancement system (The Guardian System) | |
| Experimental: Study Arm<br>The Study Arm will have the non-invasive perfusion enhancement system placed on their beds and recovery chairs. Patients will be utilizing the systems while lying in bed or sitting in the chair. | Device: Guardian System<br>* The Study arm will have the Guardian system applied to their bed and recovery chair with the intent for the patient to have the inflatable surface utilized underneath them .<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay Reduction in Acute Ischemic Stroke Patients in the Control and Study Arm Groups | The length of stay of acute ischemic stroke patients measured from the time of randomization until the the date of discharge or date of death from any cause, whichever came first. | The time frame will be up to and including 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ischemic Stroke, Motor Recovery, Length of Stay Reduction