IMAS Optimization and Applicability in Acute and Subacute Stroke.

Completed

Conditions studied: Acute Stroke

In brief

The investigator will investigate our Integrated sensor-based Motion Analysis Suite (IMAS) to objectively and quantitatively measure acute stroke patient motor status.

Key facts

Study ID

NCT05469438

Run by

Case Western Reserve University

People needed

30

Starts

2021-10-29

Expected to finish

2025-09-30

Last updated by the study team

2025-12-02

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Providing informed consent to participate in the study.
• Age 18 to 85 years old.
• Clinical presentation and neuroimaging (CTA-CTP/ MRI-MRA) consistent with the diagnosis of Acute Ischemic or Hemorrhagic Stroke.
• Preserved mental status (Glasgow coma score >12: E(4), V(5), M (4-6)).
• Presence of upper limb weakness per the NIHSS (1-2 points in the arm) and ability to perform testing (i.e., NIHSS motor score 1-2 at elbow, wrist, and finger flexion-extension) within 30 days from stroke. (Note that individuals with a prior ischemic or hemorrhagic stroke with available information pertaining superior extremity baseline strength after their previous stroke would qualify).
• Presence of upper limb weakness per the NIHSS (2 points in the arm) and ability to perform testing (i.e., NIHSS motor score 2 at elbow, wrist, and finger flexion-extension) in subacute stroke. (Note that individuals with a prior ischemic or hemorrhagic stroke with available information pertaining superior extremity baseline strength after their previous stroke would qualify).
• Baseline Modified Rankin score <4.

You may not qualify if…

• History of dementia per relative/ medical records.
• Presence of receptive aphasia at baseline or after the current acute stroke.
• Need for rapid clinical response due to conditions such as psychosis, or suicidality.
• Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, pulmonary issues, or chronic obstructive pulmonary disease);
• Amputated limbs.
• Absence of weakness as per the NIHSS (0 points = no drift for motor arm and leg items) or severe motor impairment NIHSS 4 points for motor arm).
• Stroke mimics (e.g., infections, medication effects from sedatives, electrolyte imbalances, etc.).
• Stroke worsening between assessments.

Where it is running

• Ciro Ramos Estebanez, MD., Ph.D., MBA, FNCS. — Chicago, Illinois, United States
• UH — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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