Martina Regazzetti [Healthcare Innovation Technology Lab, IRCCS San Camillo Hospital, Venice, Italy]
Zitti Mirko [Department of Human Neuroscience, “Sapienza” University, Rome, Italy ]
Lazzaro Giovanni [IRCCS San Camillo Hospital, Venice, Italy]
Federico Sara [Healthcare Innovation Technology Lab, IRCCS San Camillo Hospital, Venice, Italy]
Cieslik Blazej [Healthcare Innovation Technology Lab, IRCCS San Camillo Hospital, Venice, Italy]
Kiper Pawel [Healthcare Innovation Technology Lab, IRCCS San Camillo Hospital, Venice, Italy]
In recent years, the global incidence of spinal cord injuries (SCI), including incomplete cases (11.5 to 53.4 cases per million), has highlighted the importance of rehabilitation potential in these patients (DeVivo, 2012; Kirshblum et al., 2011). Exoskeletons, stimulating spinal neural circuits like the Central Pattern Generator (CPG), are increasingly used to aid walking (Gizzi et al., 2011). However, few studies provide adequate information on their efficacy, emphasizing the need to bridge current knowledge gaps (Sczesny-Kaiser et al., 2015). This study aimed to assess motor improvements and clinical parameters such as spasticity, muscle strength, pain, and EMG patterns post-exoskeleton treatment, contributing to advancing understanding in this field (Sczesny-Kaiser et al., 2015).
This randomized controlled study at IRCCS San Camillo (N° GR-2018-12367485) involved patients aged 18-65 with incomplete spinal cord injury (SCI), ASIA scale C or D, who did not have bone fragility, cardiopulmonary diseases, or musculoskeletal conditions that hinder walking. The experimental group underwent an 8-week traditional treatment regimen combined with 12 sessions using the EKSO-NR exoskeleton. The control group received 8 weeks of traditional neurorehabilitation focusing on muscle reinforcement, balance exercises, and walking. The primary outcome measured was walking performance, evaluated using the 10-Meters Walk Test (10MWT) and 6-Minute Walk Test (6MWT). Secondary outcomes were assessed using the Modified Ashworth Scale, Numeric Rating Scale (NRS), Lower Extremity Motor Score (LEMS, ASIA subscale), and dynamic electromyography (DEMG) during gait.
This study involved five patients: three in the control group and two in the treatment group. Patients had various lesions: three lumbar (L2-S1), one thoracic (T11-T12), and one cervical (C4-C6). Preliminary findings indicated no statistically significant differences in walking performance for both control (p = 0.571, p = 0.403) and treatment groups (p = 0.716, p = 0.354) in the 10MWT and 6MWT. Additionally, there were no significant intergroup differences in the 10MWT (p = 0.445) and 6MWT (p = 0.111). However, electromyographic (EMG) data revealed an increase in muscle contractions in the tibialis anterior and rectus femoris in the same time interval after 4 weeks of Ekso treatment compared to the control group where the number of contractions remained stable.
Given the small number of participants, the current data do not allow us to determine if training with the exoskeleton can improve motor performance during walking in terms of endurance and speed. More data are needed to define in greater detail the impact that using this device can have on walking. Additionally, it is essential to verify on a larger number of patients whether the observed trends are consistent and significant. Examining the specific mechanisms by which the exoskeleton influences muscle activity could provide valuable insights. Comprehensive research with larger cohorts and extended follow-up periods is crucial to fully understand and optimize the potential of exoskeleton-assisted rehabilitation for improving patient outcomes.
