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Completed

NCT Number: NCT04364490

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

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.

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Key information

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

S.Anna Institute

Crotone, 88900, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • unilateral stroke in the territory of middle cerebral artery, occurring at least 1 month before entry;
  • ability to follow verbal instructions without severe cognitive impairment (Mini Mental State Evaluation, MMSE> 24);
  • right-handed patients
  • signature of informed consent.

Exclusion criteria

  • bilateral impairment;
  • presence of complete hemiplegia;
  • history of traumatic injury ( e.g. fracture, joint dislocation with permanent dysmorphism after trauma) impairing the lower limb motor function;
  • botulinum toxin injections or other medication influencing the function of the lower limbs;
  • history of major affective disorders or alcohol abuse or history and/or clinical evidence of severe heart, lung, kidney, or liver diseases;
  • inability to provide informed consent.

Treatment and study plan

Copernicus noVF

Device

Advanced gait training sessions by the computerized BWS system, named Copernicus®, without visual feedback.

Copernicis VF-Plus

Device

Advanced gait training session with the addition of visual feedback ensuring a real-time interactive control of locomotor performance.

Control Group

Other

Usual care

Primary outcomes

  1. To evaluate the effects of an early rehabilitation and deambulation treatment performed using a visual feedback device.

    Time frame: up to 6 weeks after the end of treatment

    To assess, motor abilities of lower limb, gait and balance, we use the Tinetti's test.

  2. To evaluate the effects of an early rehabilitation and deambulation treatment performed using a visual feedback device.

    Time frame: up to 6 weeks after the end of treatment

    The degree of disability during activities of daily living was assessed with the Barthel Index (BI).

Secondary outcomes

  1. To evaluate the effectiveness of a novel computerized BWS sensory feedback system (Copernicus®).

    Time frame: 6 weeks after the end of treatment

    To evaluate the effectiveness of a novel computerized BWS sensory feedback system (Copernicus®) that provides information on gait performances by visual feedback extracted from wearable sensors we use the Fugl-Meyer Lower Extremities scale test (FM-LE).

Sponsors and collaborators

Lead sponsor

S.Anna Rehabilitation Institute

Other

Registry information

Official study title

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

Acronym: Copernicus

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 28, 2020
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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