Satisfaction analysis of overground gait exoskeletons in people with neurological pathology. a systematic review.

BACKGROUND: People diagnosed with neurological pathology may experience gait disorders that affect their quality of life. In recent years, research has been carried out on a variety of exoskeletons in this population. However, the satisfaction perceived by the users of these devices is not known. Therefore, the objective of the present study is to evaluate the satisfaction perceived by users with neurological pathology (patients and professionals) after the use of overground exoskeletons. METHODS: A systematic search of five electronic databases was conducted. In order to be included in this review for further analysis, the studies had to meet the following criteria: [1] the study population was people diagnosed with neurological pathology; [2] the exoskeletons had to be overground and attachable to the lower limbs; and [3]: the studies were to include measures assessing either patient or therapist satisfaction with the exoskeletons. RESULTS: Twenty-three articles were selected, of which nineteen were considered clinical trials. Participants diagnosed with stroke (n = 165), spinal cord injury (SCI) (n = 102) and multiple sclerosis (MS) (n = 68). Fourteen different overground exoskeleton models were analysed. Fourteen different methods of assessing patient satisfaction with the devices were found, and three ways to evaluate it in therapists. CONCLUSION: Users' satisfaction with gait overground exoskeletons in stroke, SCI and MS seems to show positive results in safety, efficacy and comfort of the devices. However, the worst rated aspects and therefore those that should be optimized from the users' point of view are ease of adjustment, size and weight, and ease of use.

Effects of ATLAS 2030 gait exoskeleton on strength and range of motion in children with spinal muscular atrophy II: a case series.

BACKGROUND: Children with spinal muscular atrophy (SMA) present muscle weakness and atrophy that results in a number of complications affecting their mobility, hindering their independence and the development of activities of daily living. Walking has well-recognized physiological and functional benefits. The ATLAS 2030 exoskeleton is a paediatric device that allows gait rehabilitation in children with either neurological or neuromuscular pathologies with gait disorders. The purpose is to assess the effects in range of motion (ROM) and maximal isometric strength in hips, knees and ankles of children with SMA type II after the use of ATLAS 2030 exoskeleton. METHODS: Three children (mean age 5.7 ± 0.6) received nine sessions bi-weekly of 60 min with ATLAS 2030. ROM was assessed by goniometry and strength by hand-held dynamometer. All modes of use of the exoskeleton were tested: stand up and sit down, forward and backward walking, and gait in automatic and active-assisted modes. In addition, different activities were performed during the gait session. A descriptive analysis of all variables was carried out. RESULTS: The average time of use was 53.5 ± 12.0 min in all sessions, and all participants were able to carry out all the proposed activities as well as to complete the study. Regarding isometric strength, all the measurements increased compared to the initial state, obtaining the greatest improvements for the hip flexors (60.2%) and extensors muscles (48.0%). The ROM increased 12.6% in hip and 34.1% in the ankle after the study, while knee ROM remained stable after the study. CONCLUSION: Improvements were showed in ROM and maximal isometric strength in hips, knees and ankles after using ATLAS 2030 paediatric gait exoskeleton in all three children. This research could serve as a preliminary support for future clinical integration of ATLAS 2030 as a part of a long-term rehabilitation of children with SMA. TRIAL REGISTRATION: The approval was obtained (reference 47/370329.9/19) by Comunidad de Madrid Regional Research Ethics Committee with Medical Products and the clinical trial has been registered on Clinical Trials.gov: NCT04837157.

A new lower limb portable exoskeleton for gait assistance in neurological patients: a proof of concept study.

BACKGROUND: Few portable exoskeletons following the assist-as-needed concept have been developed for patients with neurological disorders. Thus, the main objectives of this proof-of-concept study were 1) to explore the safety and feasibility of an exoskeleton for gait rehabilitation in stroke and multiple sclerosis patients, 2) to test different algorithms for gait assistance and measure the resulting gait changes and 3) to evaluate the user's perception of the device. METHODS: A cross-sectional study was conducted. Five patients were recruited (4 patients with stroke and 1 with multiple sclerosis). A robotic, one-degree-of-freedom, portable lower limb exoskeleton known as the Marsi Active Knee (MAK) was designed. Three control modes (the Zero Force Control mode, Mode 1 and Mode 3) were implemented. Spatiotemporal gait parameters were measured by the 10-m walking test (10MWT), the Gait Assessment and Intervention Tool (G.A.I.T.) and Tinetti Performance Oriented Mobility Assessment (gait subscale) before and after the trials. A modified QUEST 2.0 questionnaire was administered to determine each participant's opinion about the exoskeleton. The data acquired by the MAK sensors were normalized to a gait cycle, and adverse effects were recorded. RESULTS: The MAK exoskeleton was used successfully without any adverse effects. Better outcomes were obtained in the 10MWT and G.A.I.T. when Mode 3 was applied compared with not wearing the device at all. In 2 participants, Mode 3 worsened the results. Additionally, Mode 3 seemed to improve the 10MWT and G.A.I.T. outcomes to a greater extent than Mode 1. The overall score for the user perception of the device was 2.8 ± 0.4 95% CI. CONCLUSIONS: The MAK exoskeleton seems to afford positive preliminary results regarding safety, feasibility, and user acceptance. The efficacy of the MAK should be studied in future studies, and more advanced improvements in safety must be implemented.

Eficacia del sistema robótico de entrenamiento de la marcha tipo Lokomat en la rehabilitación de pacientes con lesión medular incompleta. Una revisión sistemática / Effectiveness of the Lokomat robotic gait training system in patients with incomplete spinal cord injury. A systematic review

Objetivo. La reeducación de la marcha es un objetivo fundamental para mejorar el estado funcional, así como para prevenir complicaciones en el paciente con lesión medular incompleta. El objetivo del presente trabajo fue realizar una revisión sistemática sobre el empleo del sistema robótico Lokomat en la rehabilitación de la marcha de pacientes con lesión medular incompleta. Estrategia de búsqueda. Se realizó una búsqueda sistemática de artículos científicos publicados, tanto en inglés como en castellano, en las bases de datos PubMed, Web of Science, ProQuest Research Library, Scopus, Medline, y en la Journal of Physical Therapy, desde noviembre del 2011 hasta mayo de 2016. Se evaluó la calidad metodológica mediante la escala de Jadad. Selección de los estudios. Un total de 12 artículos fueron finalmente seleccionados. Síntesis de resultados. Se exponen los resultados en función de las características de los estudios realizados, severidad y fase aguda o crónica de la lesión, escalas de valoración empleadas y crono-programación de las sesiones con el dispositivo Lokomat. La calidad metodológica fue baja, siendo aceptable en solo 2 de los estudios analizados. Conclusiones. Existen evidencias a favor del uso del Lokomat sobre ciertos parámetros de la marcha en pacientes afectados por lesión medular incompleta, pero no son superiores a ninguna otra técnica empleada para este tipo de pacientes. Se aconseja su uso como una herramienta coadyuvante en la rehabilitación de la marcha en la lesión medular incompleta (AU)

Objective. Gait training is crucial to improve functional status as well as to prevent complications in patients with incomplete spinal cord injury. The aim of this study was to conduct a systematic review of the use of the Lokomat robotic device on gait rehabilitation in patients with incomplete spinal cord injury. Search strategy. We performed a systematic search of scientific articles published in the databases PubMed, Web of Science, ProQuest Research Library, Scopus, Medline and Journal of Physical Therapy in both English and Spanish from November 2011 until May 2016. The methodological quality of the articles included was assessed using the Jadad scale. Article selection. A total of 12 articles were included. Summary of the results. The results are presented in terms of the characteristics of the studies, severity and whether status was acute or chronic, the scales employed and programming sessions with the Lokomat device. The methodological quality was low, and was acceptable in only two of the studies analysed. Conclusions. There is evidence in favour of using the Lokomat device on certain gait parameters in patients with incomplete spinal cord injury, but it is not superior to any other technique used for these patients. This robotic device should be used as an adjunctive tool in gait rehabilitation (AU)