NCT05579197

Myosuit Chronic Stroke Protocol

Valutazione Degli Effetti di un Dispositivo Indossabile Per Arto Inferiore (Myosuit) Sulla accettabilità e Parametri Funzionali di Pazienti Cronici Post-ictus: Studio Pilota.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A stroke is a vascular condition that can suddenly cause the loss of neurological functions. The disability derived from a stroke can imply reduced communication and limited activities of daily living in the long term. Thus, specifically walking rehabilitation is crucial in order to restore the lower limbs' function and to re-establish the social participation of patients. Robotics has been demonstrated in being a suitable and effective tool in order to assist and treat post-stroke patients, thanks to its capability to deliver intensive and task-oriented training. Specifically, the exosuits, are a sub-group of robotics devices designed in lighter materials that assist the patients by actively moving the hip, knee or ankle. Given this framework, the aim of this work is to conduct a pilot study on the usability and perceived effectiveness of a lower-limb exosuit, the Myosuit device, on post-stroke patients. The secondary aims of the study concern the evaluation of the functional performances of the patients both with and without the device and before and after the treatment.

Detailed description

A stroke, either ischemic or haemorrhagic, is a vascular condition that can suddenly cause the loss of neurological functions \[1\]. The disability derived from a stroke can imply reduced communication and limited activities of daily living in the long term. Specifically, reduced mobility and equilibrium, walking asymmetry and spasticity of the impaired limb are the principal factors related to long-term limited physical activity and moderate dependency of the patient on the caregiver \[2,3\]. A walking deficit can have severe consequences on the energetic cost and the risk of falling, as well as on the participation and personal identity of the person \[4\]. Moreover, another psychological area that can be affected is self-efficacy, defined as the individual capabilities to take actions for obtaining results. Hence, for a person affected by stroke, self-efficacy is crucial and connected to his/her adaptation to the new condition \[5\]. For these reasons, walking rehabilitation is essential to recover lower limbs' function, restore self-efficacy and re-establish the social participation of patients \[6\]. Robotics has been demonstrated in being a suitable and effective tool in order to assist and treat post-stroke patients \[7\], thanks to its capability to deliver intensive and task-oriented training. One of the most common modalities to classify robotics devices is according to their structure, and the modality to interface with the patients. In these regards, we can distinguish between exoskeletons and end-effector robots, given their characteristics to wear the patient and guide him/her through the distal handle of the mechanical chain, respectively. Moreover, among the exoskeletons, the exosuits are a sub-group of robotics devices designed in lighter materials and that assist the patients by actively moving the hip, knee or ankle. The lightweight of exosuits makes them suitable both for ecological and therapy-related settings, as well as assistance applications. It is also worth noticing that the absence of a rigid structure requires the patients to have an active component in the walking activity. Previous studies highlighted how these devices can have a supportive capacity during the propulsion phases of gait, assisting the patients throughout the walk \[8\]. The Myosuit device is a wearable exosuit capable to provide assistance during the walk, sit to stand transition and stair climb \[9\]. Its assistance is provided with an exo-tendon mechanism. More in detail, online analysis of inertial signals allows to segment the gait phases and to assist at the extension of the knee and hip \[9\]. Many previous studies show promising results in the deambulation of spinal cord injuries or patients with lower-limb disorders \[9,10\]. These results were evaluated both in terms of kinematics and the safety of the patients. However, the studies conducted to highlight the urgency for the validation of the device in bigger and different cohorts \[9,10\]. Given this framework, the aim of this work is to conduct a pilot study on the effects of a lower-limb exosuit, the Myosuit device, on post-stroke patients. The effects of the device will be analysed in terms of usability of the device, self-efficacy, and functional parameters of gait.

Conditions

• Stroke
• Ischemic Stroke
• Haemorrhagic Stroke

Interventions

Type	Name	Description
DEVICE	Lower-limb robotic intervention	The intervention proposed in this study involves the use of an exosuit for lower limbs, the Myosuit. The selection of the tasks has been done in order to replicate typical activities of daily living in a structured environment, i.e. a rehabilitation hospital. Specifically, the tasks involve walking, sit to stand, balance and stair climbing. During the phases of assessment (session 2 and session 10), other devices are be used. Specifically: * The Optogait system; for a markerless gait analysis; * The Gyko sensor; an inertial sensor that will be used at the beginning of the training for the synchronisation of the signals recorded by the Myosuit and the signal recorded by the Optogait. Finally, during all the sessions, the Polar heart rate sensor is used to constantly monitor the cardiac frequency of the patients.

Timeline

• Start date: 2022-04-07
• Primary completion: 2023-04-07
• Completion: 2023-10-10
• First posted: 2022-10-13
• Last updated: 2024-02-20

Locations

1 site across 1 country: Italy