Robotic rehabilitation for end-effector device and botulinum toxin in upper limb rehabilitation in chronic post-stroke patients: an integrated rehabilitative approach

But where is the protocol located so survivors can find it and ask their therapists to implement?

Robotic rehabilitation for end-effector device and botulinum toxin in upper limb rehabilitation in chronic post-stroke patients: an integrated rehabilitative approach

• Teresa Paolucci,
• Francesco Agostini,
• Massimiliano Mangone,
• Andrea Bernetti,
• Letizia Pezzi,
• Vitalma Liotti,
• Elena Recubini,
• Cristina Cantarella,
• Rosa Grazia Bellomo,
• Carlo D’Aurizio &
• Raoul Saggini 

Neurological Sciences (2021)Cite this article

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Abstract

Background

Determine the effects of an integrated rehabilitation protocol, including botulinum toxin and conventional rehabilitation exercise plus end-effector (EE) robotic training for functional recovery of the upper limb (UL) compared to training with the robot alone in post-chronic stroke patients with mild to severe spasticity, compared to training with the robot alone.

Methods

In this prospective, observational case-control study, stroke patients were allocated into 2 groups: robot group (RG, patients who underwent robotic treatment with EE) and robot-toxin group (RTG, patients who in addition have carried out the injection of botulinum toxin for UL recovery). All patients were assessed by Fugl-Meyer Assessment (FMA), Motricity Index (MI), modified Ashworth scale (MAS), numeric rating scale (NRS), Box and Block Test (BBT), Frenchay Arm Test (FAT), and Barthel Index (BI) at baseline (T0), T1 (end of treatment), and T2 (3 months of follow-up).

Results

Forty-four patients were included and analyzed (21RG; 23RTG). From the analysis between groups, the results suggested how there was a statistically significant difference in favor of RTG, specifically ΔT0-T1 and ΔT0-T2 for B&B p = 0.009 and p = 0.035; ΔT0-T1 and ΔT0-T2 for FAT with p = 0.016 and p = 0.031; ΔT0-T1 for MAS shoulder p = 0.016; ΔT0-T1 and ΔT0-T2 with p = 0.010 and p = 0.005 for MAS elbow; and ΔT0-T1 and ΔT0-T2 with p = 0.001 and p = 0.013 for MAS wrist.

Conclusion

Our results suggest, in line with the literature, a good efficacy in the reduction of spasticity and in the improvement of the function of the UL, with the reduction of pain, adopting a rehabilitation protocol integrated with BoTN, robot-assisted training, and traditional physiotherapy.

Introduction

Rehabilitation represents a very important focus for motor recovery after stroke which influences the neurobiology of neuronal plasticity providing controlled, repetitive, and variable patterns. After a stroke, approximately 80% of patients report a UL motor deficit with all subsequent limitations in activities of daily living and limiting social participation [1, 2].

For the functional recovery of the upper limb (UL), training with specific repetitive task exercises with progressive difficulty, goal oriented, is recommended. In addition, task-oriented exercises in the recovery of UL function should be tailored and personalized as much as possible considering the patient’s possibilities and needs [3, 4]. From these premises, robotic devices for UL open a window to define therapeutic modalities as a possible beneficial drug, in patients with a moderate-to-severe deficit after stroke, able to boost biological, neurobiological, and epigenetic changes in the central nervous system (CNS) [5]. We can consider three main functional consequences of impairments on UL function after stroke: (1) learned nonuse, (2) learned bad use, and (3) forgetting use [6], where robotic rehabilitation with both the end-effector system (EE) and the exoskeleton (ES) can be effective in the recovery alone or in association with conventional therapy. For example, during rhythmic pointing movements of the UL and the hand, end-effector and joint angles are reciprocally related in synergies and the action system is organized as a complex dynamical system [7,8,9]; then, robotic training exercises could improve the fine and purposeful motor organization of the UL as in acute as in chronic phase after stroke. Moreover, recovery of the UL function recognizes a recovery time of over 1 year that is likely mediated by a complex combination of spontaneous and learning-dependent processes, including restitution, substitution, and compensation. In particular, upper extremity impairments have chronic effects on functional independence and satisfaction in 50 to 70% of all stroke patients [10, 11]. Therefore, the rehabilitation of UL in the post-stroke patient represents a very important aspect to integrate with conventional therapy. From this point of view, robotic therapy represents a rehabilitation resource that has given very encouraging results in recent years. The UL robotic-assisted therapy combined with conventional therapy during the early rehabilitation phase after stroke is more effective than conventional therapy alone to improve gross manual dexterity, upper limb ability during functional tasks, and patient social participation [12, 13]. Also, Stephanie Hyeyoung Lee and colleagues studied that the EE robot intervention is better than the Exo-robot intervention with regard to activity and participation among chronic stroke patients with moderate-to-severe UL impairment [14]. Very interesting is the study by Mazzoleni et al., which pointed out how a haptic device in chronic stroke patients reported significant changes on the elbow spasticity [15]. Also, other authors demonstrated improvement in motor function and in muscular activation pattern after a short robotic training in chronic post-stroke spasticity of UL treated prior to the treatment with botulinum toxin; instead, in less severe spasticity, the only robotic treatment could be effective [16]. Deepening the topic, Gandolfi et al. showed that the combined use of robot-assisted UL training and botulinum toxin (BoNT) appears to be a promising therapeutic synergism to improve UL function in chronic stroke patients, but only the robot-assisted UL training contributed to improving muscle strength [17]. The robotic rehabilitation should have to include task-specific and context-specific training as principles in motor learning, and the training should target the goals that are relevant for the needs of patients.

In the context of pharmacological treatment, in association with the rehabilitation plan, the use of botulinum toxin (BT) is indicated for the treatment of focal spasticity in the hemiplegic patient, especially for the recovery of the UL [18]: BT type A improved muscle tone, physician global assessment, and disability assessment scale in upper limb spasticity and increases the Fugl-Meyer score in lower limb spasticity [19]. Also, Andringa et al. in a recent systematic review concluded that no further trials are needed to investigate BoNT for its favorable effects on resistance to passive movement of the spastic wrist and fingers, and on self-care [20]. In light of these premises and the indications of the literature regarding UL robotic rehabilitation in the post-stroke patient, the aim of our research was to determine the effects of an integrated rehabilitation protocol, including botulinum toxin and conventional rehabilitation exercise with EE robotic training for functional recovery of UL in post-chronic stroke patients with mild to severe spasticity, compared to training with the robot alone. The primary outcome was the assessment of spasticity and the secondary outcome was the recovery of UL function.

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