Acute Stroke
Conditions
Keywords
Stroke, Rehabilitation, Motor Recovery
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.
Interventions
None listed
Sponsors
Highland Instruments, Inc.
Case Western Reserve University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coefficient of Determination (R²) for Predicting Fugl-Meyer Upper Extremity Score Recovery Post-stroke. | 6 - 8 weeks post acute stroke onset | 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. |
Countries
United States
Participant flow
Pre-assignment details
38 consented, 8 did not meet eligibility, and 30 were enrolled and started.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Stroke Study 30 Acute or Sub Acute Stroke Patients | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Single Arm Stroke Study |
|---|---|
| Age, Continuous | 61.96 years STANDARD_DEVIATION 11.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fugl-Meyer | 45.6 units on a scale STANDARD_DEVIATION 14.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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.
Time frame: 6 - 8 weeks post acute stroke onset
Population: Patients with stroke
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Coefficient of Determination (R²) for Predicting Fugl-Meyer Upper Extremity Score Recovery Post-stroke. | 0.9 Coefficient of determination (Unitless) |