Pavan Arianna (IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy)
Fasano Alessio (IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy)
Cortellini Laura (IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy)
Lattanzi Stefania (IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy)
Papadopoulou Dionysia (IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy)
Insalaco Sabina (IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy)
Germanotta Marco (IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy)
Aprile Irene (IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy)
According to the World Health Organization (WHO), stroke is the leading cause of disability and the second leading cause of death worldwide, with a 30% increase expected between 2000 and 2025 [ 1 ]. Loss of upper limb dexterity represents one of the main factors of long-lasting disability in stroke patients, resulting in decreased autonomy and severe decline in quality of life [ 2 ]. In this context, rehabilitation brings benefits in terms of motor and functional recovery and cognitive and psychological improvement. In the past ten years, robotic equipment designed specifically for the neuromotor rehabilitation of the upper limb has gradually been introduced into clinical practice. [ 3 ]. The purpose of the study was to compare the effects of a robotic rehabilitation pathway, using a set of four robotic devices, before and after the implementation of a robotic treatment protocol defined on the basis of clinical outcome.
In this study, 81 patients with subacute stroke outcomes were recruited at the Don Carlo Gnocchi Foundation in Rome, including 32 patients for the Pilot Study Group (robotic treatment) and 49 for the Experimental Group (the robotic treatment protocol based on clinical outcome). Figure 1 represents the study design, included the protocol development phase. Subjects underwent a 30-session upper limb neurorehabilitation program using the following robotic devices (Figure 1): Diego, Amadeo, Pablo and Motore. Patients were assessed before (T0) and after (T1) the rehabilitation intervention using the following clinical scales: Fugl-Meyer Assessment for Upper Extremity (FMA-UE) to investigate upper extremity performance, Motricity Index (MI) to measure strength, Modified Barthel Index (mBI) for activities of daily living and the Numerical Rating Scale (NRS) for pain. In addition to the robotic treatment for upper limb recovery, patients performed daily conventional rehabilitation treatment aimed at trunk control, balance, and gait recovery. The following procedures were carried out: (a) an intragroup statistical analysis using the non-parametric Wilcoxon test to evaluate the data collected at T0 and T1 separately for the two groups; (b) an intergroup statistical analysis, using the non-parametric Mann-Whitney test, to compare the deltas of improvement (T1-T0) between the two groups.
Intragroup analysis showed significant improvement in both groups in terms of upper limb motor function (FMA-UE Pilot Group: p<0.001; FMA-UE Experimental Group: p<0.001), strength (MI Pilot Group: p=0.002; MI Experimental Group: p<0.001) and autonomy in performing activities of daily living (mBI Pilot Group: p<0.001; mBI Experimental Group: p<0.001). There was no evidence of changes in pain (NRS Pilot Group: p=0.733; NRS Experimental Group: p=0.806). Intergroup analysis (Figure 2) on deltas of improvement showed a statistically significant difference in FMA-UE (p=0.002) and MI (p<0.001), indicative of greater recovery in motor function and upper limb strength in the Experimental Group, compared with the Pilot Group.
The implementation of a customized robotic treatment protocol, using a set of 4 robotic devices, based on clinical outcome (thus allowing the type and mode of intervention to be defined) showed superiority over robotic treatment without a defined protocol. In detail, the results show an overall improvement in upper limb strength and function in subjects with acute phase stroke cerebri.
[ 1 ] Truelsen, Thomas, et al. Eur J Neurol. 2006 Jun;13(6):581-98.
[ 2 ] Nakayama, Hirofumi, et al. Arch Phys Med Rehabil. 1994 Apr; 75(4):394-398.
[ 3 ] Mehrholz, Jan, et al. Cochrane Database Syst Rev. 2018 (9): CD006876.
