IMAS Optimization and Applicability in Acute and Subacute Stroke.

NCT05469438 | Completed Results

• 1 other identifier: STUDY20190922
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Acute Stroke

Keywords

Stroke; Rehabilitation; Motor Recovery

Outcome Measures

Primary Outcomes (1)

• Coefficient of Determination (R²) for Predicting Fugl-Meyer Upper Extremity Score Recovery Post-stroke.

  The coefficient of determination (R²) quantifies how well the predictive model explains variance in Fugl-Meyer Upper Extremity recovery scores. This unitless measure ranges from -∞ to 1, with higher values indicating better model fit (i.e. better prediction). Additional Detail: A sensor suite assessed movement kinematics (e.g., time, position, velocity), and software predicted recovery from baseline characteristics. We report R² for the best-performing model predicting end-of-study FM score from day-one FM score, using leave-one-out cross-validation (\~24 degrees of freedom). Models with fewer degrees of freedom may yield lower R² due to overfitting control.

  6 - 8 weeks post acute stroke onset

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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)..

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.

Sponsors & Collaborators

• Case Western Reserve University: lead
• Highland Instruments, Inc.: collaborator

Study Sites (2)

Ciro Ramos Estebanez, MD., Ph.D., MBA, FNCS.

Chicago, Illinois, 60612, United States

Location

UH

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Kylie Phillips (Clinical Research Regulatory Specialist III)
• Organization: University Hospitals Cleveland Medical Center (Case Western Reserve University)

kylie.phillips@uhhospitals.org

(440)328-7964

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: July 21, 2022
• Study Start: October 29, 2021
• Primary Completion: August 31, 2023
• Study Completion: September 30, 2025
• Last Updated: December 2, 2025
• Results First Posted: December 2, 2025

Record last verified: 2025-11

Locations

US (2)