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| Name | Class |
|---|---|
| Highland Instruments, Inc. | INDUSTRY |
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The investigator will investigate our Integrated sensor-based Motion Analysis Suite (IMAS) to objectively and quantitatively measure acute stroke patient motor status.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria
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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)..
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ciro Ramos Estebanez, MD., Ph.D., MBA, FNCS. | Chicago | Illinois | 60612 | United States | ||
| UH |
38 consented, 8 did not meet eligibility, and 30 were enrolled and started.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Single Arm Stroke Study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
30 Acute or Sub Acute Stroke Patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Stroke Study | 30 Acute or Sub Acute Stroke Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients with stroke | Posted | Number | Coefficient of determination (Unitless) | 6 - 8 weeks post acute stroke onset |
|
Occurrence of adverse events was assessed at all visits through study completion, an average of 8 weeks.
There were no adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm Stroke Study | 30 Acute or Sub Acute Stroke Patients | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kylie Phillips (Clinical Research Regulatory Specialist III) | University Hospitals Cleveland Medical Center (Case Western Reserve University) | (440)328-7964 | kylie.phillips@uhhospitals.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 2, 2019 | Jun 27, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 2, 2019 | Jun 27, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Cleveland |
| Ohio |
| 44106 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Fugl-Meyer | Upper Limb Fugl-Meyer Score (range: 0-54 ) built from a total of:
| Mean | Standard Deviation | units on a scale |
|
Single Arm- no intervention
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|
|
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
There is a generic non-disclosure agreement about the IMAS technology.
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |