NCT04364490

Rehabilitative Efficacy of a Visual Feedback Device for Locomotion of Post-stroke Patients

Study of the Rehabilitative Efficacy of Copernicus®, a Visual Feedback Device for the Early Start to Locomotion of Post-stroke Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: S.Anna Rehabilitation Institute · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

We tested the feasibility and efficacy of a novel body-weight support (BWS) gait training system with visual feedback, called Copernicus®. This computerized device provides highly comfortable, regular and repeatable locomotion in hemiplegic patients, training the ability to transfer weight loading alternately on both feet through visual real-time monitoring of gait parameters.

Detailed description

Gait disorders are very common in stroke patients (about 80%) increasing the risk of falls in performing daily activities and also reducing the global quality of life. Gait disorders in these patients are characterized by asymmetry in postural and weight distribution during quiet standing, as well as, by reduced gait speed, that is considered one of the most important outcome measure of locomotor recovery. Restoring gait functions (speed, asymmetry and balance) after stroke is one of the major therapeutic goals in post-stroke rehabilitation and a plethora of recovering strategies have been proposed. In this study we tested the feasibility and efficacy of a novel body-weight support (BWS) gait training system with visual feedback, called Copernicus®. This computerized device provides highly comfortable, regular and repeatable locomotion in hemiplegic patients, training the ability to transfer weight loading alternately on both feet through visual real-time monitoring of gait parameters Copernicus®, a sensory system for the early start of the locomotion appears as an elliptical cylinder of about 1 meter high on which two completely slideing positions are prepared by means if a guide fixed along the oval surface of the device. Each post has a support on which the patient's healthy side of the subject is placed, above which a brace for the support of the body is attached and weared by the patient in the verticalization; Front of the patient is a tablet that provides visual feedback during the exercises. The patient wears shoes on a pair of soles with piezo-resistive sensors that record for each foot the pressure exerted on the three areas of the foot (outer, inner and heel). The recorded data is then processed and transmitted to the tablet within a virtual reinforcement environment. The patient will be able to know his performance and achieved results and perceive them within a real scenario. The sensing pads measure the support times for each side and the number of changes. The device is so structured as to allow the simultaneous treatment of two patients.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Copernicus noVF	Advanced gait training sessions by the computerized BWS system, named Copernicus®, without visual feedback.
DEVICE	Copernicis VF-Plus	Advanced gait training session with the addition of visual feedback ensuring a real-time interactive control of locomotor performance.
OTHER	Control group	Usual care

Timeline

• Start date: 2018-06-01
• Primary completion: 2018-12-31
• Completion: 2019-12-01
• First posted: 2020-04-28
• Last updated: 2020-04-28

Locations

1 site across 1 country: Italy