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Table 3 Baseline and follow-up assessments for each participant at each time point

From: Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol

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

  1. Unless otherwise specified, assessments are administered and scored by standardized BE’s.
  2. 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.
  3. 2Post-Intervention Evaluation occurs between 16–20 weeks post-randomization.
  4. 36-month Post-Randomization Evaluation occurs between 24–28 weeks post-randomization.
  5. 412-month Post-Randomization Evaluation occurs between 50–64 weeks post-randomization.
  6. 5Items at given time points are measured by local site team personnel and not by BE’s.