IMAS Optimization and Applicability in an Acute Stroke Setting.

Acute Stroke Clinical Trial

Official title:

IMAS Optimization and Applicability in an Acute Stroke Setting.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05469438
• Other study ID #: STUDY20190922
• Status: Recruiting
• Start date: October 29, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: Case Western Reserve University
• Contact: Megan O'Neill Miller
• Phone: 2168444720
• Email: megan.miller3[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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). (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. Baseline Modified Rankin score <4.

Exclusion Criteria:

1. History of alcohol or drug abuse within the past 6 months as self-reported;

2. History of schizophrenia, schizoaffective disorder, other psychosis, bipolar illness, alcohol/drug abuse within the past year;

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

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

5. History of dementia per relative/ medical records.

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

7. Amputated limbs.

8. 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).

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

10. Stroke worsening between assessments.

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Locations

Country	Name	City	State
United States	Ciro Ramos Estebanez, MD., Ph.D., MBA, FNCS.	Chicago	Illinois
United States	UH	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	Highland Instruments, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomechanical Assessments of movements from the Fuegl-Meyer Scale. Prediction of motor recovery post-stroke.	The sensor suite will assess patient movement from the Fuegl-Meyer Scale through kinetics (e.g., time to perform the movement (seconds), position, distance (mm), velocity mm/sec), and kinematics (e.g., angular velocity (mm/sec).	6 - 8 weeks post acute stroke onset
Secondary	Barthel Index	The Barthel Index questionnaire measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing.	6 - 8 weeks post acute stroke onset.