N/A
N=30
IMAS Optimization and Applicability in Acute and Subacute Stroke.
Acute Stroke
Bottom Line
View on ClinicalTrials.gov: NCT05469438 ↗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
| Outcome | Result | p-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.
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.