Background Effective rehabilitative therapies are needed for patients with long-term deficits after stroke. Methods In this multicenter, randomized, controlled trial involving 127 patients with moderate-to-severe upper-limb impairment 6 months or more after a stroke, we randomly assigned 49 patients to receive intensive robot-assisted therapy, 50 to receive intensive comparison therapy, and 28 to receive usual care. Therapy consisted of 36 1-hour sessions over a period of 12 weeks. The primary outcome was a change in motor function, as measured on the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke, at 12 weeks. Secondary outcomes were scores on the Wolf Motor Function Test and the Stroke Impact Scale. Secondary analyses assessed the treatment effect at 36 weeks. Results At 12 weeks, the mean Fugl-Meyer score for patients receiving robot-assisted therapy was better than that for patients receiving usual care (difference, 2.17 points; 95% confidence interval [CI], −0.23 to 4.58) and worse than that for patients receiving intensive comparison therapy (difference, −0.14 points; 95% CI, −2.94 to 2.65), but the differences were not significant. The results on the Stroke Impact Scale were significantly better for patients receiving robot-assisted therapy than for those receiving usual care (difference, 7.64 points; 95% CI, 2.03 to 13.24). No other treatment comparisons were significant at 12 weeks. Secondary analyses showed that at 36 weeks, robot-assisted therapy significantly improved the Fugl-Meyer score (difference, 2.88 points; 95% CI, 0.57 to 5.18) and the time on the Wolf Motor Function Test (difference, −8.10 seconds; 95% CI, −13.61 to −2.60) as compared with usual care but not with intensive therapy. No serious adverse events were reported. Conclusions In patients with long-term upper-limb deficits after stroke, robot-assisted therapy did not significantly improve motor function at 12 weeks, as compared with usual care or intensive therapy. In secondary analyses, robot-assisted therapy improved outcomes over 36 weeks as compared with usual care but not with intensive therapy. (ClinicalTrials.gov number, NCT00372411.)

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In this paper, we present the design and characterization of a novel ankle robot developed at the Massachusetts Institute of Technology (MIT). This robotic module is being tested with stroke patients at Baltimore Veterans Administration Medical Center. The purpose of the ongoing study is to train stroke survivors to overcome common foot drop and balance problems in order to improve their ambulatory performance. Its design follows the same guidelines of our upper extremity designs, i.e., it is a low friction, backdriveable device with intrinsically low mechanical impedance. Here, we report on the design and mechanical characteristics of the robot. We also present data to demonstrate the potential of this device as an efficient clinical measurement tool to estimate intrinsic ankle properties. Given the importance of the ankle during locomotion, an accurate estimate of ankle stiffness would be a valuable asset for locomotor rehabilitation. Our initial ankle stiffness estimates compare favorably with previously published work, indicating that our method may serve as an accurate clinical measurement tool.