An observational study in Stroke, sponsored by Northwestern University. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Northwestern University · Observational
This study will contribute to the field of stroke rehabilitation research by expanding the investigator's understanding of the neural mechanisms responsible for the development and expression of abnormal flexion synergy, a primary movement impairment due to stroke. The study will longitudinally evaluate motor tract morphology and motor impairment/function in an attempt to develop early neuroimaging-based predictors of the development of flexion synergy and its impact on reaching and hand recovery (6 month). The study will utilize quantitative motor testing (kinematics and kinetics) to measure motor impairment and reaching and hand function. Both neuroimaging and quantitative motor testing will be conducted within 96 hours-, 2 weeks-, 3 months-, and 6 months-post stroke. The knowledge gained by this study will provide crucial structural and functional neuroimaging evidence that demonstrates the timeline of progressive ipsi- and contralesional motor pathway (including bulbospinal pathways) changes and the associated development of flexion synergy that grossly impacts reaching and hand function in individuals with moderate to severe stroke.
7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.
This study's planned enrollment of 120 is below the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →Northwestern University is the lead sponsor of 1,398 studies on the registry; 201 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients will be recruited from the in-patient stroke unit based upon the study inclusion criteria.
Exclusion Criteria:
Change in fractional anisotropy
Fractional anisotropy is a quantitative measure of fiber density, axonal diameter, and myelination in the corticofugal, corticoreticulospinal, and corticorubrospinal tracts derived from the diffusion tensor imaging dataset.
Time frame: Change in fractional anisotropy will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
Change in complexity
Complexity (alpha) is an index of the non-Gaussian diffusion dynamics within the corticofugal, corticoreticulospinal, and corticorubrospinal tracts derived from the diffusion tensor imaging dataset.
Time frame: Change in complexity will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
Change in mean diffusivity
Mean diffusivity is a measure of neural tract integrity quantifying the rotationally invariant magnitude of water diffusion within neural tissue defined by the 3-dimensional diffusion tensor.
Time frame: Change in mean diffusivity will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
Change in radial diffusivity
Radial diffusivity is a measure of neural membrane integrity quantifying the average of the two small-axis values of water diffusion within neural tissue defined by the 3-dimensional diffusion tensor.
Time frame: Change in radial diffusivity will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
Change in axial diffusivity
Axial diffusivity is a measure of neural tract direction quantifying the long-axis value of water diffusion within neural tissue defined by the 3-dimensional diffusion tensor.
Time frame: Change in axial diffusivity will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
Change in maximum reaching distance
Quantitative evaluation of reaching accounting for the expression of both flexion synergy and weakness by calculating distance from reaching kinematics data during ballistic outward reaches against various abduction loads.
Time frame: Change in maximum reaching distance will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
Change in maximum hand aperture
Quantitative evaluation of hand opening accounting for the expression of both flexion synergy and weakness by calculating the area of a pentagon formed by the finger tips from hand kinematics data obtained at various abduction loads.
Time frame: Change in maximum hand aperture will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
Change in maximum grasp force
Quantitative evaluation of hand closing accounting for the expression of both flexion synergy and weakness by calculating the mean surface grasp force of the hand at various abduction loads.
Time frame: Change in maximum grasp force will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
Predictive capacity of diffusor tensor imaging (DTI) for 6-month reaching and hand performance
Changes in structural morphology measured acutely will be evaluated as early predictors for chronic reaching and hand performance. Receiver operating characteristic (ROC) curve analysis will be used to evaluate the discrimination potential of each acute imaging measure in predicting chronic moderate versus severe motor impairment for each of the reaching and hand performance measures.
Time frame: Changes in structural morphology from 48 hours to 2-weeks post-stroke will be evaluated as early predictors for the 6-month reaching and hand performance outcomes including ROC curve analysis.
Relationship between DTI and quantitative motor testing
The relationship between each structural morphology metric and each quantitative motor testing metric will be evaluated.
Time frame: Relationships between metrics will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
Change in Fugl-Meyer Motor Assessment
Qualitative and clinical assessment of general motor impairment of arm following stroke. The scale evaluates movement impairment of the arm through observation. The scale ranges from 0-66 points with 66 indicating the best score.
Time frame: Change in Fugl-Meyer Motor Assessment will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
Change in Action Research Arm Test
Qualitative and clinical assessment of activity limitation (function) of the arm following stroke. The scale focusses on reaching, grasping, and releasing objects of various sizes. The scale ranges from 0-57 with 57 indicating the best score.
Time frame: Change in Action Research Arm Test will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
Change in Stroke Impact Scale
Structured interview to assess domains of the ICF (International Classification of Functioning, Disability and Health) in individuals following stroke. The domains include self-reported physical problems, memory and thinking, control of emotions, communication, daily activities, home and community mobility, the affected hand, participation and life roles, and global recovery. Each domain score is transformed to a scale of 0-100 with 100 being the best score.
Time frame: Change in Stroke Impact Scale will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
Plan to share: Yes — Final research data will be shared openly and timely in accordance with NIH Data Sharing Policy (https://grants.nih.gov/grants/policy/data\_sharing/). Data sharing will occur through the primary repositories of Northwestern University DigitalHub (https://prism.northwestern.edu/) and Open Science Framework (https://osf.io/). Data will be exported from the internal RedCap study data base in spreadsheet format and will be deidentified and coded. Data will be available through speaking engagements and publications, presentations at scientific symposia and seminars. Data sharing in the above repositories will be phased in time with acceptance for publication of the primary outcome paper near the end of the fifth year and then with each subsequent publication. Publications will include DOIs for the data repositories.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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