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: ).

Upper Limb Robotic Rehabilitation After Stroke: A Multicenter, Randomized Clinical Trial / I. Aprile, M. Germanotta, A. Cruciani, S. Loreti, C. Pecchioli, F. Cecchi, A. Montesano, S. Galeri, M. Diverio, C. Falsini, G. Speranza, E. Langone, D. Papadopoulou, L. Padua, M. Carrozza, S. Lattanzi, L. Cortellini, P. Papadopoulou, G. Liberti, F. Panzera, P. Mitrione, D. Ruzzi, G. Rinaldi, C. Galli, S. Insalaco, L. Padua, F. De Santis, P. Spinelli, S. Marsan, I. Bastoni, A. Pellegrino, T. Petitti, C. Pazzaglia, C. Di Blasi, A. Castagna, C. Grosso, P. Ammenti, D. Cattaneo, L. Azzinnaro, D. Barbieri, S. Cassani, C. Corrini, M. Meotti, R. Parelli, A. Spedicato, M. Zocchi, M. Loffi, D. Manenti, L. Negri, F. Gramatica, G. Gower, F. Noro, L. Medici, R. Garattini, F. Bariselli, M. Luli, V. Rota, M. Ricca, S. Negrini, E. Giannini, A. Gabrielli, B. Deidda, B. Gnetti, P. Beatini, G. Giansanti, A. Lograsso, S. Callegari, F. Converti, A. Pizzi, A. Romanelli, G. De Luca, F. Vannetti, E. Simoncini, M. Martini, E. Peccini, L. Avila, M. Gabrielli, M. Barilli, E. Bertocchi, G. Giannarelli, E. Lerda, M. Vasoli, P. Rossi, V. Marsili, B. Tognoli, A. Bertolini, G. Vastola, M. Colella, R. Mosca, G. Competiello, A. Chiusano, A. Della Vecchia, S. Pasqualina, M. Pagliarulo, V. Remollino, E. Langone, M. Magliulo, G. Araneo, L. Galantucci, N. Lioi, F. Marrazzo, S. Larocca, R. Calia, S. Benevento, O. Toscano, Lategana. - In: JOURNAL OF NEUROLOGIC PHYSICAL THERAPY. - ISSN 1557-0576. - 44:1(2020 Jan), pp. 3-14. [10.1097/NPT.0000000000000295]

Upper Limb Robotic Rehabilitation After Stroke: A Multicenter, Randomized Clinical Trial

D. Cattaneo
Membro del Collaboration Group
;
S. Negrini;
2020

Abstract

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: ).
randomized controlled trial; rehabilitation; robotics; stroke; upper extremity;
Settore MED/48 -Scienze Infermie.e Tecniche Neuro-Psichiatriche e Riabilitattive
gen-2020
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/828962
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