IMAS Optimization and Applicability in Acute and Subacute Stroke.

NCT ID: NCT05469438

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-29
• Study Completion Date: 2025-09-30

Brief Summary

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

Detailed Description

The investigator will evaluate the feasibility of our IMAS to assess 30 stroke subjects in 5 sessions (the first 4 proximal to stroke onset and the last session ~6-8 weeks post stroke). The investigator will test IMAS in 30 acute stroke subjects; and extract quantitative movement kinematic/kinetic metrics descriptive of subjects' motor behavior (e.g., arm movement speed, smoothness). Subjects will undergo a series of upper limb focused assessments including Fugl Meyer, Barthel Index, and Orpington Prognostic Scale assessments. The investigator will also collect demographics, and stroke clinical information such as imaging data.

Conditions

Acute Stroke

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Providing informed consent to participate in the study.

2. Age 18 to 85 years old.

3. Clinical presentation and neuroimaging (CTA-CTP/ MRI-MRA) consistent with the diagnosis of Acute Ischemic or Hemorrhagic Stroke.

4. Preserved mental status (Glasgow coma score >12: E(4), V(5), M (4-6)).

5. 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).

6. 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).

7. Baseline Modified Rankin score <4.

Exclusion Criteria

1. History of dementia per relative/ medical records.

2. Presence of receptive aphasia at baseline or after the current acute stroke.

3. Need for rapid clinical response due to conditions such as psychosis, or suicidality.

4. Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, pulmonary issues, or chronic obstructive pulmonary disease);

5. Amputated limbs.

6. 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).

7. Stroke mimics (e.g., infections, medication effects from sedatives, electrolyte imbalances, etc.).

8. Stroke worsening between assessments.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Highland Instruments, Inc.

INDUSTRY

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Ciro Ramos Estebanez, MD., Ph.D.

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Chicago, Illinois, United States

UH

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

STUDY20190922

Identifier Type: -

Identifier Source: org_study_id