Clinical trial NCT05469438: IMAS Optimization and Applicability in an Acute Stroke Setting.
Official title: IMAS Optimization and Applicability in an Acute Stroke Setting.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Stroke
Keywords: Stroke
Rehabilitation
Motor Recovery
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Highland Instruments, Inc.
First posted: 2022-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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)..

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.

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). (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.

Primary outcomes:
measure: Biomechanical Assessments of movements from the Fuegl-Meyer Scale. Prediction of motor recovery post-stroke.
timeFrame: 6 - 8 weeks post acute stroke onset
Secondary outcomes:
measure: Barthel Index
timeFrame: 6 - 8 weeks post acute stroke onset.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ciro Ramos Estebanez, MD., Ph.D., MBA, FNCS.
state: Illinois
city: Cleveland
country: United States
facility: UH
state: Ohio
Study officials:
References: