Effectiveness of Robot-Assisted Upper Limb Training on Spasticity, Function and Muscle Activity in Chronic Stroke Patients Treated With Botulinum Toxin: A Randomized Single-Blinded Controlled Trial

Marialuisa Gandolfi, Nicola Valè, Eleonora Kirilova Dimitrova, Stefano Mazzoleni, Elena Battini, Mirko Filippetti, Alessandro Picelli, Andrea Santamato, Michele Gravina, Leopold Saltuari, Nicola Smania, Marialuisa Gandolfi, Nicola Valè, Eleonora Kirilova Dimitrova, Stefano Mazzoleni, Elena Battini, Mirko Filippetti, Alessandro Picelli, Andrea Santamato, Michele Gravina, Leopold Saltuari, Nicola Smania

Abstract

Background: The combined use of Robot-assisted UL training and Botulinum toxin (BoNT) appear to be a promising therapeutic synergism to improve UL function in chronic stroke patients. Objective: To evaluate the effects of Robot-assisted UL training on UL spasticity, function, muscle strength and the electromyographic UL muscles activity in chronic stroke patients treated with Botulinum toxin. Methods: This single-blind, randomized, controlled trial involved 32 chronic stroke outpatients with UL spastic hemiparesis. The experimental group (n = 16) received robot-assisted UL training and BoNT treatment. The control group (n = 16) received conventional treatment combined with BoNT treatment. Training protocols lasted for 5 weeks (45 min/session, two sessions/week). Before and after rehabilitation, a blinded rater evaluated patients. The primary outcome was the Modified Ashworth Scale (MAS). Secondary outcomes were the Fugl-Meyer Assessment Scale (FMA) and the Medical Research Council Scale (MRC). The electromyographic activity of 5 UL muscles during the "hand-to-mouth" task was explored only in the experimental group and 14 healthy age-matched controls using a surface Electromyography (EMGs). Results: No significant between-group differences on the MAS and FMA were measured. The experimental group reported significantly greater improvements on UL muscle strength (p = 0.004; Cohen's d = 0.49), shoulder abduction (p = 0.039; Cohen's d = 0.42), external rotation (p = 0.019; Cohen's d = 0.72), and elbow flexion (p = 0.043; Cohen's d = 1.15) than the control group. Preliminary observation of muscular activity showed a different enhancement of the biceps brachii activation after the robot-assisted training. Conclusions: Robot-assisted training is as effective as conventional training on muscle tone reduction when combined with Botulinum toxin in chronic stroke patients with UL spasticity. However, only the robot-assisted UL training contributed to improving muscle strength. The single-group analysis and the qualitative inspection of sEMG data performed in the experimental group showed improvement in the agonist muscles activity during the hand-to-mouth task. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03590314.

Keywords: electromyography; rehabilitation; robotics; spasticity; upper limb.

Figures

Figure 1
Figure 1
The upper limb robot-assisted training setting.
Figure 2
Figure 2
Flow diagram of the study.
Figure 3
Figure 3
EMGs muscle activity during the “hand-to-mouth” task in healthy controls.
Figure 4
Figure 4
EMGs muscle activity during the “hand-to-mouth” task in stroke patients before and after the upper limb Robot-assisted training.
Figure 5
Figure 5
Lesions displayed on the magnetic resonance imaging brain template and electromyographic activity of the five upper limb muscles during the “hand-to-mouth” task was explored using a surface Electromyography (EMGs) in two patients. (A) Top left: Lesion Mapping (patient 1). Magnetic resonance imaging showed a lesion involving the left fronto-parietal lobes. Brodmann areas 48, 40, 39, 6, 44, 45, 3, 7, 22, 41, 2, 42, 4, 19, 43, 37, 21,47,9, 46, 1, 18, 23, 10 (MRIcron software, http://www.mricro.com/mricron). The electromyographic activity of the 5 UL muscles during the “hand-to-mouth” task was explored using a surface Electromyography (EMGs). (B) Top right: Lesion Mapping (patient 2). Magnetic resonance imaging showed a lesion involving the left frontal lobe. Brodmann areas 48, 45, 44, 6, 46, 43, 4, 3, 47, 32, 9, 38, 22, 10 (MRIcron software, http://www.mricro.com/mricron). The electromyographic activity of the 5 UL muscles during the “hand-to-mouth” task was explored using a surface Electromyography (EMGs).

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