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

Status unconfirmed · Not applicable

Conditions studied: Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT03673241

Run by

TurnCare Inc.

People needed

120

Starts

2018-10-30

Expected to finish

2019-03-28

Last updated by the study team

2018-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Good Samaritan Hospital — San Jose, California, United States

Full record on ClinicalTrials.gov

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