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

• Published in: Journal of neurologic physical therapy Vol. 44; no. 1; pp. 3 - 14
• Main Authors: Aprile, Irene, Germanotta, Marco, Cruciani, Arianna, Loreti, Simona, Pecchioli, Cristiano, Cecchi, Francesca, Montesano, Angelo, Galeri, Silvia, Diverio, Manuela, Falsini, Catuscia, Speranza, Gabriele, Langone, Emanuele, Papadopoulou, Dionysia, Padua, Luca, Carrozza, Maria Chiara
• Format: Journal Article
• Language: English
• Published: United States Academy of Neurologic Physical Therapy, APTA 01-01-2020; Neurology Section - American Physical Therapy Association
• Subjects: Aged; Aged, 80 and over; Clinical trials; Female; Humans; Male; Middle Aged; Postoperative period; Recovery of Function - physiology; Robotics; Stroke; Stroke - physiopathology; Stroke Rehabilitation - methods; Surgical outcomes; Treatment Outcome; Upper Extremity - physiopathology
• ISSN: 1557-0576; 1557-0584
• DOI: 10.1097/NPT.0000000000000295

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.
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.
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.
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).