Participants were assessed at baseline (prerandomization), post-intervention (end of therapy), 6 months, and 12 months (end of study) after randomization by clinicians masked to treatment assignment and standardized in administration of primary and secondary outcome assessments.5 (link) A 12-monthchange in the log-transformed Wolf Motor Function Test (WMFT) time score was the primary outcome. The WMFT time score is a mean of 15 hierarchically arranged timed arm movements and hand dexterity tasks.15 (link)–18 (link) If a task could not be completed in 2 minutes (ie, 120 seconds), a time score of 121 seconds was assigned. A log transformation is used to accommodate for the nonnormality in the raw time score.
Secondary outcomes included the 12-month change in WMFT time score (minimum clinically important difference, 19 seconds faster, 16% of the range on the dominant side and unknown on the nondominant side19 (link)) and improvement in participant- reported Stroke Impact Scale (SIS), version 3.0, hand subscale score (percentage with improvement ≥25 points). Because the SIS hand function range is 0 to 100 points, participants with SIS hand function scores of 75 or higher at baseline (n = 15) were excluded from this analysis. The minimal detectable change and minimal clinically important difference for the SIS hand function subscale are 25.9 points and 17.8 points, respectively.20 (link) The primary end point was the end of study (12 months after randomization; mean, 13.5 months after stroke), while end of therapy (16 weeks after randomization; mean, approximately 22 weeks after stroke) was a secondary end point.
Patients (or their designated representatives or caregivers) were contacted by monthly telephone calls to review health status, health care utilization, medications, and adverse events. Adverse events were reported regarding 3 independent characteristics: expectedness, relation to study, and severity.5 (link)
Secondary outcomes included the 12-month change in WMFT time score (minimum clinically important difference, 19 seconds faster, 16% of the range on the dominant side and unknown on the nondominant side19 (link)) and improvement in participant- reported Stroke Impact Scale (SIS), version 3.0, hand subscale score (percentage with improvement ≥25 points). Because the SIS hand function range is 0 to 100 points, participants with SIS hand function scores of 75 or higher at baseline (n = 15) were excluded from this analysis. The minimal detectable change and minimal clinically important difference for the SIS hand function subscale are 25.9 points and 17.8 points, respectively.20 (link) The primary end point was the end of study (12 months after randomization; mean, 13.5 months after stroke), while end of therapy (16 weeks after randomization; mean, approximately 22 weeks after stroke) was a secondary end point.
Patients (or their designated representatives or caregivers) were contacted by monthly telephone calls to review health status, health care utilization, medications, and adverse events. Adverse events were reported regarding 3 independent characteristics: expectedness, relation to study, and severity.5 (link)
