A multicenter randomized controlled trial on the upper limb robotic rehabilitation in subacute stroke using a set of robotic and sensor-based devices: Feasibility of the InTeReSt study

Aprile, I.; Germanotta, M.; Cruciani, A.; Loreti, S.; Pecchioli, C.; Montesano, A.; Galeri, S.; Cecchi, F.; Diverio, M.; Falsini, C.; Speranza, G.; Langone, E.; Padua, L.; Lattanzi, S.; Cortellini, L.; Papadopoulou, D.; Liberti, G.; Panzera, F.; Mitrione, P.; Ruzzi, D.; Rinaldi, G.; Insalaco, S.; De Santis, F.; Spinelli, P.; Marsan, S.; Bastoni, I.; Pellegrino, A.; Petitti, T.; Pazzaglia, C.; Castagna, A.; Grosso, C.; Ammenti, P.; Cattaneo, D.; Azzinnaro, L.; Barbieri, D.; Cassani, S.; Corrini, C.; Meotti, M.; Parelli, R.; Spedicato, A.; Zocchi, M.; Loffi, M.; Manenti, D.; Negri, L.; Gramatica, F.; Gower, V.; Noro, F.; Medici, L.; Garattini, R.; Bariselli, F.; Luli, M.; Ricca, M.; Negrini, S.; Giannini, E.; Gabrielli, A.; Deidda, B.; Gnetti, B.; Beatini, P.; Giansanti, G.; Lograsso, A.; Callegari, S.; Converti, F.; Pizzi, A.; Romanelli, A.; De Luca, G.; Vannetti, F.; Simoncini, E.; Martini, M.; Peccini, E.; Avila, L.; Gabrielli, M. A.; Barilli, M.; Bertocchi, E.; Giannarelli, G.; Lerda, E.; Vasoli, M.; Rossi, P.; Marsili, V.; Tognoli, B.; Bertolini, A.; Vastola, G.; Colella, M.; Mosca, R.; Competiello, G.; Chiusano, A.; Vecchia, A. D.; Pasqualina, S.; Pagliarulo, M.; Remollino, V.; Santarsiero, R.; Magliulo, M.; Araneo, G.; Galantucci, L.; Lioi, N.; Marrazzo, F.; Larocca, S.; Calia, R.; Benevento, S.; Toscano, O.; Michele, L.

doi:10.1007/978-3-030-01845-0_102

The aim of this study is to test the feasibility of a new protocol of upper limb treatment, using a set of four robotic and sensor-based devices in sub-acute stroke patients in a multicenter study aimed to evaluate the efficacy of robotic therapy compared with conventional therapy. Participants are recruited in 8 centers and randomized to either the robotic group or the conventional group. The outcomes were selected according to the International Classification of Functioning, Disability and Health domains, to evaluate body function, activities and participation. A total of 247 participants were randomized, 224 of whom received the allocated intervention. Our results demonstrate the feasibility of our rehabilitation protocol in a multicenter clinical trial and in clinical practice.

A multicenter randomized controlled trial on the upper limb robotic rehabilitation in subacute stroke using a set of robotic and sensor-based devices: Feasibility of the InTeReSt study

Aprile I.;Germanotta M.;Cruciani A.;Loreti S.;Pecchioli C.;Montesano A.;Galeri S.;Cecchi F.;Diverio M.;Falsini C.;Speranza G.;Langone E.;Padua L.;Lattanzi S.;Cortellini L.;Papadopoulou D.;Liberti G.;Panzera F.;Mitrione P.;Ruzzi D.;Rinaldi G.;Insalaco S.;De Santis F.;Spinelli P.;Marsan S.;Bastoni I.;Pellegrino A.;Petitti T.;Pazzaglia C.;Castagna A.;Grosso C.;Ammenti P.;Cattaneo D.;Azzinnaro L.;Barbieri D.;Cassani S.;Corrini C.;Meotti M.;Parelli R.;Spedicato A.;Zocchi M.;Loffi M.;Manenti D.;Negri L.;Gramatica F.;Gower V.;Noro F.;Medici L.;Garattini R.;Bariselli F.;Luli M.;Ricca M.;Negrini S.;Giannini E.;Gabrielli A.;Deidda B.;Gnetti B.;Beatini P.;Giansanti G.;Lograsso A.;Callegari S.;Converti F.;Pizzi A.;Romanelli A.;De Luca G.;Vannetti F.;Simoncini E.;Martini M.;Peccini E.;Avila L.;Gabrielli M. A.;Barilli M.;Bertocchi E.;Giannarelli G.;Lerda E.;Vasoli M.;Rossi P.;Marsili V.;Tognoli B.;Bertolini A.;Vastola G.;Colella M.;Mosca R.;Competiello G.;Chiusano A.;Vecchia A. D.;Pasqualina S.;Pagliarulo M.;Remollino V.;Santarsiero R.;Magliulo M.;Araneo G.;Galantucci L.;Lioi N.;Marrazzo F.;Larocca S.;Calia R.;Benevento S.;Toscano O.;Michele L.

2019-01-01

Abstract

The aim of this study is to test the feasibility of a new protocol of upper limb treatment, using a set of four robotic and sensor-based devices in sub-acute stroke patients in a multicenter study aimed to evaluate the efficacy of robotic therapy compared with conventional therapy. Participants are recruited in 8 centers and randomized to either the robotic group or the conventional group. The outcomes were selected according to the International Classification of Functioning, Disability and Health domains, to evaluate body function, activities and participation. A total of 247 participants were randomized, 224 of whom received the allocated intervention. Our results demonstrate the feasibility of our rehabilitation protocol in a multicenter clinical trial and in clinical practice.