Robot-assisted upper limb training combined with Botulinum toxin injection in the treatment of upper limb spasticity: a randomised single-blinded controlled trial

This is in multiple sclerosis patients so your doctor will not have enough brains to translate this to stroke patients.

Robot-assisted upper limb training combined with Botulinum toxin injection in the treatment of upper limb spasticity: a randomised single-blinded controlled trial

Marialuisa Gandolfi^1*, Nicola Valè¹, Eleonora Kirilova Dimitrova¹, Stefano Mazzoleni², Elena Battini², Maria Donata Benedetti¹, Alberto Gajofatto¹, Francesco Ferraro³, Matteo Castelli⁴, Maruo Camin⁴, Mirko Filippetti¹, Carola De Paoli¹, Elena Chemello¹, Alessandro Picelli^1,5, Jessica Corradi¹, Andreas Waldner⁶, Leopold Saltuari^7,8 and Nicola Smania^1,5

• ¹Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy
• ²The BioRobotics Institute, Scuola Superiore Sant' Anna, Polo Sant' Anna Valdera, Pontedera, Italy
• ³Section of Neuromotor Rehabilitation, Department of Neuroscience, ASST Carlo Poma, Mantova, Italy
• ⁴Centro di riabilitazione Franca Martini—ATSM ONLUS, Trento, Italy
• ⁵UOC Neurorehabilitation, AOUI Verona, Verona, Italy
• ⁶Department of Neurological Rehabilitation, Private Hospital Villa Melitta, Bolzano, Italy
• ⁷Research Department for Neurorehabilitation South Tyrol, Bolzano, Italy
• ⁸Department of Neurology, Hochzirl Hospital, Zirl, Austria

Background : Integration of robotics and upper limb rehabilitation in people with multiple sclerosis (PwMS) has rarely been investigated.

Objective: To compare the effects of robot-assisted hand training against non-robotic hand training on upper limb activity in PwMS. To compare the training effects on hand dexterity, muscle activity, and upper limb dysfunction as measured with the International Classification of Functioning.

Methods: This single-blind, randomized, controlled trial involved 44 PwMS (Expanded Disability Status Scale:1.5–8) and hand dexterity deficits. The experimental group (n = 23) received robot-assisted hand training; the control group (n = 21) received non-robotic hand training. Training protocols lasted for 5 weeks (50 min/session, 2 sessions/week). Before (T0), after (T1), and at 1 month follow-up (T2), a blinded rater evaluated patients using a comprehensive test battery. Primary outcome: Action Research Arm Test. Secondary outcomes: Nine Holes Peg Test; Fugl-Meyer Assessment Scale–upper extremity section; Motricity Index; Motor Activity Log; Multiple Sclerosis (MS) Quality of Life−54; Life Habits assessment—general short form and surface electromyography.

Results: There were no significant between-group differences in primary and secondary outcomes. Electromyography showed relevant changes providing evidence increased activity in the extensor carpi at T1 and T2.

Conclusion: The training effects on upper limb activity and function were comparable between the two groups. However, robot-assisted training demonstrated remarkable effects on upper limb use and muscle activity. https://clinicaltrials.gov NCT03561155.

Introduction

Multiple sclerosis (MS) is the most common non-traumatic cause of neurologic disability in young adults worldwide (1). The major causes of disability are inflammatory demyelination and axonal loss², which result in the hallmark motor, sensory, cognitive, and autonomic dysfunctions found in people with MS (2, 3). In the first year of disease onset up to 66% of patients will develop upper limb impairment that will continue to worsen over the following three decades (3–5) and diminish participation and quality of life (5, 6) Temporal fluctuations and fatigue render clinical management extraordinarily complex (3).

In the last decade, integration of robot-assisted devices in upper limb training programs has gained increasing interest for their capability to provide early, intensive, task-specific and multisensory stimulation especially in stroke patients (7). There is consensus on the effectiveness of upper limb rehabilitation also in people with MS (8). In their review, Lamers et al. emphasized the importance of multidisciplinary rehabilitation to improve upper limb capacity, along with body function and they suggested that upper limb capacity could be enhanced by robot-assisted training (8). Despite differences in sample characteristics and methodologies, the literature generally supports the benefits of upper limb robot-assisted training in people with MS. However, studies differ considerably in primary outcomes (activity vs. function), study design [uncontrolled vs. randomized controlled trial [RCT]], and therapy content and dosage. Only two controlled trials on upper limb robot-assisted training in people with MS have used devices designed for rehabilitating the proximal upper limb (shoulder and elbow) (9, 10). No studies to date have been performed using a robot-assisted device specifically designed for the hand in people with MS.

The Amadeo®(Tyromotion-Austria) is a modern, mechatronic end-effector robotic device. Its most distinctive feature is that it simulates natural grasping motion and executes automated movement sequences. Results from its application in stroke rehabilitation suggest that robot-assisted hand rehabilitation reduces motor impairment and increases use of the affected hand, with possible generalization to the entire upper limb (11, 12). It is not clear, however, whether these improvements can translate to increased upper limb use in everyday activities (11).

The primary aim of this study was to compare the effects of robot-assisted hand training and robot-unassisted rehabilitation on upper limb activity. The secondary aim was to compare the training effects on hand dexterity and upper limb function, disability, and quality of life. We hypothesized that, because it boosts greater use of the hand, upper limb activity would improve more after robot-assisted hand training than after non-robotic training. To explore the potential mechanisms involved in such improvements the electromyographic activity of 6 upper limb muscles was investigated. Given the multiplicity of symptoms that often need to be addressed in MS, the integration of robotics and rehabilitation holds promise for developing high-intensity, repetitive, task-specific, interactive treatment of upper limb impairment.