Table 3.
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.