Background and Purpose: After stroke, only 12% of survivors obtain complete upper limb (UL) functional recovery, while in 30% to 60% UL deficits persist. Despite the complexity of the UL, prior robot-mediated therapy research has used only one robot in comparisons to conventional therapy. We evaluated the efficacy of robotic UL treatment using a set of 4 devices, compared with conventional therapy.
Methods: In a multicenter, randomized controlled trial, 247 subjects with subacute stroke were assigned either to robotic (using a set of 4 devices) or to conventional treatment, each consisting of 30 sessions. Subjects were evaluated before and after treatment, with follow-up assessment after 3 months. The primary outcome measure was change from baseline in the Fugl-Meyer Assessment (FMA) score. Secondary outcome measures were selected to assess motor function, activities, and participation.
Results: One hundred ninety subjects completed the posttreatment assessment, with a subset (n = 122) returning for follow-up evaluation. Mean FMA score improvement in the robotic group was 8.50 (confidence interval: 6.82 to 10.17), versus 8.57 (confidence interval: 6.97 to 10.18) in the conventional group, with no significant between-groups difference (adjusted mean difference −0.08, P = 0.948). Both groups also had similar change in secondary measures, except for the Motricity Index, with better results for the robotic group (adjusted mean difference 4.42, P = 0.037). At follow-up, subjects continued to improve with no between-groups differences.
Discussion and Conclusions: Robotic treatment using a set of 4 devices significantly improved UL motor function, activities, and participation in subjects with subacute stroke to the same extent as a similar amount of conventional therapy. Video Abstract is available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A291).
Only 12% of stroke survivors obtain complete upper limb (UL) functional recovery after 6 months from stroke.1 In the remaining 88%, UL motor deficits persist with a negative impact on their level of activities2–4 and participation,5 according to the International Classification of Functioning, Disability and Health (ICF).6
Robotic therapy has been proposed as a viable approach for the rehabilitation of the UL, as a way to increase the amount and intensity of the therapy,7 and to standardize the treatment,8 by providing complex but controlled multisensory stimulation.7 Moreover, because of their built-in technology in terms of sensors and actuators, robotic devices can provide quantitative measure about the user’s dexterity.9 A large number of scientific articles on robot-assisted rehabilitation after stroke have been published, analyzing the effects of robotics alone,10–18 or in conjunction with conventional therapy.19–24 Nowadays, the use of robotic rehabilitation in addition to conventional therapy is recommended in some of the current stroke guidelines.25
Regarding the efficacy of robotic rehabilitation when compared with other treatments, the available scientific data are not conclusive. In comparing robotic and conventional treatment, some studies did not find an overall significant effect in favor of robotic therapy11,26,27: others showed a greater effect of robotic therapy than conventional therapy.28 However, in the latter case, the results must be interpreted with caution because the quality of the evidence was low or very low, owing to the variations between the trials in intensity, duration, and amount of training, type of treatment, participant characteristics, and measurements used. Finally, according to the most recent meta-analysis,29 it is not clear whether the difference between robotic therapy and other interventions (as conventional therapy) is clinically meaningful for the persons with stroke.
Almost all studies of robotic therapy have focused on the effects of the use of 1 device, compared with a conventional therapy approach. However, despite the complexity of the anatomy and the motor function of whole UL, especially the hand, almost all commercial devices act on a limited number of joints and a limited workspace. Conversely, during conventional therapy, the whole UL is routinely treated and the 3-dimensional space explored. Because of this, it is very difficult to compare the effects of 1 robotic device with conventional approaches. Therefore, it would be desirable to use devices that allow treatment of the entire UL (from shoulder to hand), in a workspace similar to that required in daily activities. Moreover, using more than 1 device new personnel organizational models can be adopted, wherein 1 physical therapist supervises more than 1 patient, thereby increasing the sustainability of the treatment.15,21,30
The aim of the current study was to evaluate, in subjects with subacute stroke, the efficacy of standardized UL robotic rehabilitation (using an organizational model in which 1 physical therapist supervises 3 subjects, each treated using a set of 4 robots and sensor-based devices), compared with UL conventional therapy. Outcomes of interest were selected to reflect effects on function, activities, and participation (per the ICF) […]