Grants and Contracts Details
Primary aims of the trial: To determine whether there is an overall treatment effect among 3 dosing groups (sham+mCIMT, 2mA+mCIMT and 4mA+mCIMT) immediately after the 2-week intervention in the Fugl-Meyer Upper-Extremity scale (FM-UE, a measure of motor impairment). Secondary outcomes are Wolf Motor Function Test time score (WFMT, a measure of functional motor activity time score) and Stroke Impact Scale(SIS) Hand Subscale (a measure of the quality of life). The sustained treatment effect will be assessed at 1 month and 3 months post-intervention. Secondary aims: To confirm that the proposed intervention is safe (no significant differences in rate of adverse events), tolerable (no significant differences in discomfort as measured by Visual-Analog-Scale), and feasible to administer in a multi-site trial (>80% of subjects complete the treatment protocol and no unexplained/unresolved variability by site) Exploratory Aim: To investigate whether wCST-LL (structural assessment of the integrity of descending motor tract) or MEPs (functional assessment of the integrity of descending motor tract) or a combination of both are correlated with changes in FM-UE scale; and to evaluate the utility of each as biomarkers for subject selection criteria for the confirmatory Phase III study.
|Effective start/end date
|8/15/18 → 7/21/21
- University of Cincinnati: $39,698.00
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