Original Title: Plataforma para la rehabilitación de la marcha en pacientes con patologías del sistema nervioso central

Authors' objectives: To assess the scientific evidence on the effectiveness and safety of C-Mill VR-based therapy, as well as to explore the perspective of patients with central nervous system disorders on its use for gait and balance rehabilitation.

Authors' results and conclusions: The systematic review identified a total of 12 studies published in the last decade concerning the effectiveness and safety of the C-Mill VR system. This exhaustive review examined a diverse set of studies assessing the effectiveness of the C-Mill VR system for various neurological conditions, namely degenerative cerebellar ataxia, poliomyelitis, hereditary spastic paraplegia, developmental coordination disorder (in children), Parkinson´s disease, and stroke. In the field of degenerative cerebellar ataxia, a quasi-experimental study with a pre/post-test design provided an interesting perspective on C-Mill VR rehabilitation. In the case of poliomyelitis, a cross-sectional descriptive observational study reports on the effects of the system on patients with this condition, providing a unique clinical perspective. The use of C-Mill VR-based rehabilitation in patients with hereditary spastic paraplegia was addressed in a randomised clinical trial, yielding valuable information on its safety and efficacy in this specific population. Regarding developmental coordination disorder, one quasi-experimental pre/post-test study and one cross-sectional observational descriptive study have been reported, providing a range of views and indicating the relevance of the C-Mill VR system in children. Parkinson´s disease was addressed in three publications, one reporting a quasi-experimental pre/post-test study, one a case series and one a non-randomised clinical trial, these providing us with diverse data on the effects of C-Mill VR rehabilitation in patients with Parkinson´s disease. In the context of stroke, four studies were found ranging from quasi-experimental pre/post-test to non-randomised and randomised clinical trial designs, together contributing substantially to the literature on C-Mill VR-based rehabilitation in patients with a history of stroke. No qualitative studies were found addressing the experiences and preferences of patients regarding the C-Mill VR gait and balance rehabilitation system in the context of this analysis. Conclusions Conclusions for clinical practice by disorder type Conclusions on the effectiveness and safety of C-Mill-based treatment for: Degenerative cerebellar ataxia Improvement was observed in certain tests related to obstacle avoidance and dynamic stability of patients with degenerative cerebellar ataxia after treatment with the C-Mill system, according to a single study. Nonetheless, the evidence is inconclusive when considering all the tests analysed. On the other hand, a reduction was noted in the number of falls after training, which suggests an improvement in stability. It is important to bear in mind that the level of confidence in the results is low, and therefore, these findings must be interpreted with caution. Poliomyelitis One observational study provides information on the effectiveness of treatment with the C-Mill system in patients with sequelae of poliomyelitis, but the results are inconclusive, as it provides no direct evidence of clinical effects in this set of patients. Further, the level of confidence in the results was low. To date, there is insufficient evidence available to assess the safety of using the C-Mill system in these patients. Hereditary spastic paraplegia According to a single clinical trial, significant improvements were observed in gait adaptability using the C-Mill system, compared to standard rehabilitation. Nevertheless, it is important to highlight the low level of confidence in the outcomes measured. Regarding safety, no serious adverse events related to the intervention were identified. Coordination disorder The two studies retrieved found significant improvements in terms of walking adaptability and cognitive skills in children with this condition, though we must interpret these findings with caution due to the low level of confidence in the results. To date, we have not found specific data regarding the safety of using the C-Mill system in children with this condition. Parkinson´s disease The available evidence suggests that training with C-Mill can improve gait speed, balance, and quality of life in patients with Parkinson’s disease, regardless of their level of instability. Nonetheless, it is important to note that confidence in these results is very low, and hence, they should be interpreted with caution. To date, no detailed information is available on adverse events or safety issues associated with the use of C-Mill in patients with Parkinson’s disease. Stroke The studies retrieved agree regarding the positive effects of training with the C-Mill system in patients with stroke in all the tests assessed, although the level of confidence was moderate for its effects on walking speed and adaptability as well as cognitive performance, and very low for the other tests analysed. The lack of detailed information on adverse events or safety problems related to these therapies means that we cannot properly assess the associated risks. Patient perspective: The views of patients reported in studies on degenerative cerebellar ataxia, coordination disorder and stroke sequelae consistently reveal satisfaction and perception of benefits by both participants and their caregivers. This positive view translates to a positive impact on quality of life, supported by the high rate of recommendation of the training programmes and improvements in walking confidence. The positive perceptions related to physical capacity support the efficacy of these programmes in various neurological conditions. To make an overall assessment of effectiveness, it is essential to consider subjective factors, underlining the importance of patient experience and feedback from caregivers to fully understand rehabilitation outcomes.

Authors' methods: A systematic review was conducted to evaluate the effectiveness and safety of gait and balance rehabilitation based on the use of the C-Mill VR system, to provide an impartial and accurate assessment to support informed decision-making in this field.

Authors' identified further research: Given the low level of confidence in the evidence overall, there is a need for further research with more rigorous methods to draw more robust conclusions on the effectiveness and safety of treatment using the C-Mill system in patients with central nervous system disorders. It is key to carry out more high-quality studies with more rigorous research designs and more representative samples to improve our understanding of the benefits and potential risks associated with this type of intervention. Such additional studies would help to strengthen the body of evidence available and provide a clearer picture of the role of the C-Mill system in the rehabilitation of patients with central nervous system disorders.

Project Status: Completed

Year Published: 2024

URL for published report: https://www.euskadi.eus/contenidos/informacion/2024_osteba_publicacion/eu_def/adjuntos/E-24-06-Plataforma_para_la_rehabilitacion.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>