Trial Outcomes & Findings for IMAS Optimization and Applicability in Acute and Subacute Stroke. (NCT NCT05469438)
NCT ID: NCT05469438
Last Updated: 2025-12-02
Results Overview
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.
COMPLETED
30 participants
6 - 8 weeks post acute stroke onset
2025-12-02
Participant Flow
38 consented, 8 did not meet eligibility, and 30 were enrolled and started.
Participant milestones
| Measure |
Single Arm
Single Arm Stroke Study
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IMAS Optimization and Applicability in Acute and Subacute Stroke.
Baseline characteristics by cohort
| Measure |
Single Arm Stroke Study
n=30 Participants
30 Acute or Sub Acute Stroke Patients
|
|---|---|
|
Age, Continuous
|
61.96 years
STANDARD_DEVIATION 11.62 • n=9 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Fugl-Meyer
|
45.6 units on a scale
STANDARD_DEVIATION 14.5 • n=9 Participants
|
PRIMARY outcome
Timeframe: 6 - 8 weeks post acute stroke onsetPopulation: Patients with 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.
Outcome measures
| Measure |
Single Arm
n=30 Participants
Single Arm- no intervention
|
|---|---|
|
Coefficient of Determination (R²) for Predicting Fugl-Meyer Upper Extremity Score Recovery Post-stroke.
|
0.9 Coefficient of determination (Unitless)
|
Adverse Events
Single Arm Stroke Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kylie Phillips (Clinical Research Regulatory Specialist III)
University Hospitals Cleveland Medical Center (Case Western Reserve University)
Results disclosure agreements
- Principal investigator is a sponsor employee There is a generic non-disclosure agreement about the IMAS technology.
- Publication restrictions are in place
Restriction type: OTHER