German Clinical Trials Register

Acronym/abbreviation of the study

XoSoft

URL of the study

http://www.xosoft.eu

Brief summary in lay language

XoSoft is a project funded by the European Commission aiming at developing a soft exoskeleton for the lower extremities. It is intended to support people with mobility impairments due to senso-motoric deficits. Existing prototypes are typically rigid structures, resulting in heavy and bulky devices which have a relatively high risk of causing pressure ulcers. For XoSoft, light materials will be used. It will not be used to help people with complete loss of sensomotoric functions; however, it will support the reduced functions. It will consist of different modules (ankle, knee, hip) that may be worn together or individually. XoSoft will be developed with a user-centered design approach and with 4 generations of prototypes (alpha, beta1, beta2, gamma). The basic functionality of these prototypes will be assessd in this study. The primary goal of the study is to assess the basic functionality. The secondary goals are the recording of movement patterns (joint angles, moments, muscle activity) of the lower extremities with and without the exoskeleton during activities of daily living. This information is necessary to inform further development of prototypes. For each generation of prototypes, three healthy, and each three people with stroke, incomplete spinal cord injury, and frailty will be measured. The testing will follow the same protocol for each generation. The basic functionality will be tested using questionnaires and written reports. Movement analysis will be done with a three-dimensional, camera-marker-based system, in addition to force plates and a surface electromyography system. Descriptive statistical analysis will be performed

Brief summary in scientific language

XoSoft is a project conducted under the framework of European Union's Horizon 2020 that is currently developing a soft lower-limb exoskeleton to assist people with mobility restrictions due a partial loss of sensory or motor function. Typically, the existing exoskeletons have a rigid structure that is heavy weight, bulky and is a risk for lesions due to excessive pressure to the skin. In contrast, XoSoft will have a flexible and adaptable structure. Its design will be lightweight due to the basic structure and the fact that assistance requires low power consumption (e.g. batteries). XoSoft is not intended to substitute complete loss of function like already existing exoskeletons, but rather assist the user in a tailored manner. To achieve the latter, XoSoft will consist of different modules (i.e. ankle, knee, hip) which can be operated alone or in combination. XoSoft is a user centred design lower limb exoskeleton using smart soft robotics, biomimetic controlled actuation and connected health data feedback and interface. Advanced textiles and smart materials are being developed to create sensing, variable stiffness joints and flexible tactile sensors. Control will be biomimetic to identify the user’s motion and intention and to determine and provide the appropriate level of assistance. In this study, the concept will be tested for its basic functionality. XoSoft will be developed in four iterative development steps which will result in four prototypes (Alpha, Beta 1, Beta 2, and Gamma). These prototypes will be tested for their basic functionality in the ZHAW Institute of Physiotherapy movement laboratory. Testing will be carried out at each stage using three control subjects who are without any movement impairment, and three groups comprising three subjects with a mild level of gait impairment (stroke, iSCI, frailty). The same measurement protocol will be performed across the testing of all prototypes. Primarily, the study assesses the basic functionality of a prototype lower limb exoskeleton during common locomotion tasks. The secondary objectives are to quantify kinematics, kinetics and muscular activity of the lower extremities and trunk limb exoskeleton during common locomotion tasks, to inform the development of future prototypes. Primary outcome: A report on the basic functionality of the prototype lower limb exoskeleton Secondary outcome: Descriptive analysis of the difference in kinematics, kinetics and muscular activity between user groups and prototype configurations