Original Title: Exoesqueletos para la recuperación funcional de la marcha en pacientes con patologías del sistema nervioso central como la esclerosis múltiple, ictus y/o lesiones medulares post-traumatismo

Authors' objectives: 1)  To identify, synthetise, analyse and evaluate the scientific evidence available concerning the efficacy/effectiveness and safety of exoskeletons for functional gait recovery in adult patients with central nervous system damage associated with multiple sclerosis, stroke, or traumatic spinal injury. 2)  To understand patients’ views and expectations regarding the use of exoskeletons in rehabilitation treatment. 3)  To identify, synthetise, analyse and evaluate the scientific evidence available on the cost and cost-effectiveness and safety of exoskeletons for functional gait recovery in adult patients with central nervous system damage caused by multiple sclerosis, stroke and traumatic spinal injury. And then, based on the data collected, - To draw up a report to support decision-making in the Spanish National Health System on the clinical utility and use of exoskeletons based on the best available evidence.

Authors' results and conclusions: For this report, a total of 31 publications were thoroughly assessed. These selected publications comprised 10 systematic reviews and meta-analyses of randomized clinical trials, 1 systematic review focused on clinical practice guidelines, 17 studies using qualitative methods, and additionally, 3 studies focusing on cost analysis. MULTIPLE SCLEROSIS Three systematic reviews on the use of exoskeletons for gait rehabilitation in patients with multiple sclerosis were analysed. These reviews included between 10 and 17 studies and demonstrated that robot-assisted gait rehabilitation using exoskeletons is effective in improving speed, endurance and balance in patients with multiple sclerosis. Exoskeleton-based therapy was found to be more beneficial in patients with the most severe levels of disability, while conventional treatments were more effective in patients with less disability and greater gait speed. Notably, exoskeleton-based therapy also improved other (non-motor) outcomes, such as spasticity, fatigue, pain, psychological well-being, and quality of life. The systematic reviews emphasised the importance of robot-assisted rehabilitation as a support to conventional physiotherapy, by providing more complex and controlled multi-sensory stimulation and allowing better quantification of the intervention dose. Conclusions – The use of robotic exoskeletons as part of the treatment of patients with multiple sclerosis has produced promising results. In particular, significant improvements have been observed in balance and gait, this being most marked in patients with higher levels of disability. – These advances are not limited to the short term; rather they also last in the medium term, consolidating the view that exoskeleton-based rehabilitation is effective. – Nonetheless, it is important to underline that further research is needed. The safety of this rehabilitation modality must be carefully addressed, and other potential benefits for patients with multiple sclerosis should be explored. Ongoing research in this field is essential to help us fully understand the reach and implications of using exoskeletons in comprehensive care for this disease. – In essence, current results are promising and suggest that exoskeletons have the potential to improve quality of life in patients with multiple sclerosis, but there is a need for a balanced approach that combines innovation with scientific rigour to ensure the efficacy and safety of this intervention in clinical settings. STROKE All four publications included -one systematic review of clinical practice guidelines and three systematic reviews of randomised clinical trials- analysed the evidence on the effects of exoskeleton-based rehabilitation in patients with a history of stroke. The systematic review included 10 clinical practice guidelines from various regions/countries published between January 2010 and October 2020. The RCT reviews analysed the efficacy and safety of exoskeletons in patients with stroke, and each included between 13 and 24 trials. The meta-analyses did not find statistically significant differences between exoskeleton-based and conventional therapy regarding patient recovery as measured by variables such as motor disability, mobility, gait speed, fitness, balance, and activities of daily living. Some reviews found positive results in terms of improvements in balance with the use of exoskeletons, but the evidence remains limited and further research is required to draw definitive conclusions. Conclusions – First, findings highlight the great importance of early gait rehabilitation for the recovery of patients after stroke. – Regarding exoskeleton-based rehabilitation, though positive effects have been reported on certain aspects of gait, it should be noted that the current evidence is limited. – The results obtained to date present a promising outlook for the benefits of exoskeletons for stroke patients, but more comprehensive, largescale studies are needed to better understand their potential reach and impact in post-stroke recovery. – Comparisons between robot-assisted and conventional rehabilitation have made an important finding, namely, that exoskeleton-assisted rehabilitation may be a more effective option for stroke patients who cannot walk independently. – To better understand the effects and potential of exoskeletons in stroke rehabilitation, there is a need to boost research in this field. Further, the development of specific clinical practice guidelines is an essential step to standardise therapeutic approaches and ensure that exoskeletons are more effectively integrated into rehabilitation protocols, thereby maximising benefits for patients. SPINAL INJURY Three systematic reviews provided evidence on the efficacy of exoskeletons in patients with spinal injury. They observed beneficial effects in terms of improvements in gait, muscle strength and functioning in patients with incomplete spinal cord injury. Nevertheless, these results should be interpreted with caution due to the heterogeneity of the studies and the limitations of some trials. In general, it was concluded that the use of exoskeletons, such as Lokomat, may be beneficial in the rehabilitation of patients with incomplete spinal cord injury by improving patient walking ability and quality of life. Conclusions – Exoskeleton-based rehabilitation seems to have positive effects on multiple aspects of recovery. Notable improvements have been reported in terms of spasticity reduction, as well as ability to walk, distance walked, and muscle strength in patients with spinal cord injury. These results suggest great potential in the use of exoskeletons as a part of therapeutic approaches to improve functioning and quality of life in these patients. – The use of exoskeletons in individuals with spinal cord injury is not correlated with an increase in perceived pain. This finding is key since it implies that the use of this technology does not compromise patient well-being and opens the door to more effective and pain-free rehabilitation. – Nonetheless, further studies need to be conducted with strong methodological designs and larger samples, to consolidate and broaden these findings, given the importance of obtaining robust and generalizable evidence on the effects and safety of exoskeletons in the context of spinal cord injury. More comprehensive research would enable a fuller understanding of the benefits and implications of this innovative technology in the rehabilitation of these patients, paving the way for its effective implementation in clinical practice. PATIENT'S PERSPETIVES The 17 qualitative studies included examined the use of robotic exoskeletons for gait rehabilitation. They analysed benefits, barriers, and recommendations related to the deployment of exoskeletons in hospital rehabilitation of neurological patients, as well as its feasibility. These studies included a total of 259 patients and used various types of exoskeletons. There was great variability in the duration, frequency and number of rehabilitation sessions. Patients and physiotherapists reported high levels of satisfaction, underlining physical, psychological and social improvements. The studies assessed identified technical challenges and resource limitations and discussed recommendations for the future development of exoskeletons. – The effectiveness and safety of exoskeletons in the process of rehabilitation were rated positively by both patients and physiotherapists. – Nonetheless, key areas for ongoing improvement have been identified. Improvements in the comfort of using exoskeletons including reductions in their weight emerge as aspects requiring further attention. These considerations are key to ensuring that the experience of patients is the least uncomfortable possible and that devices are more ergonomic in design. – From this perspective, a key lesson is the importance of close collaboration between exoskeleton developers and final users. Such a close relationship enables adjustment and tailoring of the devices to meet individual needs, thereby optimising their fit and effectiveness. Further, positive attitudes and backing from physiotherapists are essential in the success of exoskeleton-based rehabilitation, these professionals supporting patients during the process of recovery. COSTS In terms of costs, three studies that assessed the efficiency of robotic exoskeleton training in the rehabilitation of people with spinal cord injury or a history of stroke were identified; all three were classified as low-to-moderate quality, and their results were analysed and synthesised. Two assessed the cost-effectiveness of the intervention and the other its budgetary implications. The results obtained indicate that a strategy based on robot-assisted training for achieving functional gait recovery was cost-effective compared to conventional locomotor training and that its use in place of conventional therapy resulted in cost savings in the hospitals studied. – Given the limited and low-quality evidence obtained, definitive conclusions cannot be drawn concerning whether the utilization of robotic exoskeletons for locomotor therapy is more cost-effective or cost-saving than standard treatment in patients with central nervous system damage. – It is important to conduct economic evaluations under clinical practice conditions, using comparable methods and outcome measures suited to the context of the Spanish National Health System.

Authors' methods: We performed a systematic review to assess: 1) the efficacy/effectiveness and safety of exoskeletons for improving gait, 2) the views and expectations of patients with gait impairment due to multiple sclerosis, stroke or spinal injury, and 3) the cost and cost-effectiveness of exoskeletons for improving gait. The following types of publications were included in the search: clinical practice guidelines, health technology assessment reports, systematic reviews of clinical trials (with or without meta-analysis), systematic reviews of qualitative studies, qualitative studies, and economic evaluation studies. The search was limited to studies published from 2015 onwards. The FLC critical appraisal tool was used to assess the methodological quality of the publications selected. The publications concerning patient views and expectations were summarised in narrative form and evaluated using the Critical Appraisal Skills Programme tool. The final report was reviewed by experts relevant to this field including leading clinicians from various specialties. Specifically, these expert reviewers included a neurologist, neurorehabilitation physiotherapists, and a representative of patients with multiple sclerosis (president of the patient association for this disease).

Project Status: Completed

Year Published: 2024

URL for published report: https://www.euskadi.eus/contenidos/informacion/osteba_publicacion/eu_def/adjuntos/Exoesqueletos-23-2024.pdf

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government</p>