Table 3 |
||||
| Baseline and follow-up assessments for each participant at each time point | ||||
| Outcome Assessment | Baseline1 | Post-Intervention2 | 6-mo Post Randomization3 | 12-mo Post Randomization4 |
| Patient Health Questionnaire, (PHQ-9) [37,38] | X5 | X | X | X |
| NIH Stroke Scale (NIHSS) [32,39-41] | X5 | X | X | X |
| WMFT, 15 timed items | X | X | X | X |
| WMFT, 2 strength items | X | X | X | X |
| WMFT Functional Ability Scale, 15 items (WMFT- FAS)[42,43] | X | X | X | X |
| Stroke Impact Scale (SIS) | X | X | X | X |
| Cognitive Battery – 5 items | X | X | ||
| · Short Blessed Memory Orientation & Concentration Test[44] | X | X | ||
| · D-KEFS Verbal Fluency Test[45] | X | X | ||
| · Hopkins Verbal Learning Test, Revised[46] | X | X | ||
| · Digits Span Backward | X | X | ||
| · Color Trails 1 & 2 [47,48] | X | X | ||
| Upper Extremity Fugl-Meyer, Motor (UEFM) [49,50] | X | X | X | X |
| Satisfaction with Life Scale (SWLS)[51-53] | X | X | X | X |
| Arm Muscle Torque Test [54] | X | X | X | X |
| AsTex Sensory Index [55] | X | X | X | X |
| Motor Activity Log, 28 item (MAL-28)[56] | X | X | X | |
| EQ5D [57] | X | X | X | X |
| Confidence in Arm & Hand Measure (CAHM) | X | X | X | X |
| Reintegration to Normal Living Index (RNLI) [58,59] | X | X | X | X |
| Single-Item Quality of Life Measure (SQOL) [60,61] | X | X | X | X |
| Physiologic Measures | X | X | X | X |
| Monthly Telephone Follow-up5 | X | X | X | |
| Post-Intervention Exit Interview5 | X | |||
| Final Study Exit Interview5 | X | |||
Unless otherwise specified, assessments are administered and scored by standardized BE’s.
1Randomization occurs after baseline and between 14–106 days post stroke; thus participant and all study personnel are blinded to treatment group assignment at the baseline evaluation.
2Post-Intervention Evaluation occurs between 16–20 weeks post-randomization.
36-month Post-Randomization Evaluation occurs between 24–28 weeks post-randomization.
412-month Post-Randomization Evaluation occurs between 50–64 weeks post-randomization.
5Items at given time points are measured by local site team personnel and not by BE’s.
Winstein et al. BMC Neurology 2013 13:5 doi:10.1186/1471-2377-13-5