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N/A N=30

IMAS Optimization and Applicability in Acute and Subacute Stroke.

Acute Stroke

Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Coefficient of Determination (R²) for Predicting Fugl-Meyer Upper Extremity Score Recovery Post-stroke. — 0.9 Coefficient of determination (Unitless)

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Case Western Reserve University
Primary completion
Aug 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Coefficient of Determination (R²) for Predicting Fugl-Meyer Upper Extremity Score Recovery Post-stroke.
0.9

Summary

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

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05469438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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