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. Author manuscript; available in PMC: 2017 Sep 11.
Published in final edited form as: N Engl J Med. 2010 Apr 16;362(19):1772–1783. doi: 10.1056/NEJMoa0911341

Table 2.

Changes in Primary and Secondary Outcomes at 12 Weeks.*

Outcome Robot-Assisted Therapy vs. Usual Care Robot-Assisted Therapy vs. Intensive Comparison Therapy
Robot-Assisted
Therapy (N = 25)
Usual Care
(N = 27)
Mean Difference
(95% CI)
P Value Robot-Assisted
Therapy (N = 47)
Intensive Comparison
Therapy (N = 46)
Mean Difference
(95% CI)
P Value
Change in score on Fugl-Meyer Assessment 1.11±1.01 −1.06±1.00 2.17 (−0.23 to 4.58) 0.08 3.87±1.05 4.01±1.06 −0.14 (−2.94 to 2.65) 0.92

Change in time on Wolf Motor Function Test 3.13±2.96 7.54±2.97 −4.41 (−11.52 to 2.70) 0.22 −3.96±3.00 −4.89±3.00 0.93 (−7.03 to 8.89) 0.82

Change in score on Stroke Impact Scale 4.61±2.36 −3.03±2.34 7.64 (2.03 to 13.24) 0.009 6.31±1.68 5.77±1.67 0.54 (−3.87 to 4.94) 0.81

Change in score on pain scale −0.81±0.39 0±0.38 −0.81 (−1.73 to 0.11) 0.08 −0.61±0.29 0.24±0.30 −0.84 (−1.62 to−0.06) 0.03

Change in score on Modified Ashworth Scale −0.03±0.11 −0.04±0.11 0.01 (−0.25 to 0.26) 0.95 −0.07±0.09 0.12±0.09 −0.19 (−0.42 to 0.04) 0.10
*

Plus-minus values are means +SE. Patients receiving usual care were enrolled in the study for 16 months, and those receiving robot-assisted therapy were enrolled for 24 months. The analysis of robot-assisted therapy versus usual care included only patients receiving therapy during the same time period. The analysis of robot-assisted therapy versus intensive comparison therapy included all patients who underwent randomization and were evaluated. Values have been adjusted for baseline scores, the Comorbidity Disease Index score, and the medical center as a fixed effect. For patients who missed the 12-week assessment, the next post-treatment assessment, if available, was used.

All P values are two-sided, with a significance level of 0.022 to adjust for the two treatment comparisons and interim monitoring for the treatment effect.

On this scale, a reduction in the score indicates improvement in the condition being evaluated.