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

April 23, 2020 updated by: Loris Pignolo, S.Anna Rehabilitation Institute

Study of the Rehabilitative Efficacy of Copernicus®, a Visual Feedback Device for the Early Start to 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Crotone, Italy, 88900
        • S.Anna Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental VF group

Inpatients with a diagnosis of first-ever ischemic stroke in post acute phase, admitted for rehabilitation to S.Anna rehabilitation Institute.

The intervention consist of 2-h of rehabilitation daily sessions, five weekly over 6 weeks. During one hour of treatment, this group perform advanced gait training sessions by the computerized BWS system without visual feedback; during second hour of treatment, during the second hour of treatment patients are treated according to conventional therapy consisting of exercises for passive and active mobilization of lower limbs, trunk control, standing, deambulation.
Device: Copernicus noVF
Advanced gait training sessions by the computerized BWS system, named Copernicus®, without visual feedback.
Experimental: Experimental VF+ group

Inpatients with a diagnosis of first-ever ischemic stroke in post acute phase, admitted for rehabilitation to S.Anna rehabilitation Institute.

The intervention consist of 2-h of rehabilitation daily sessions, five weekly over 6 weeks. During one hour of treatment, this group perform the same advanced gait training session with the addition of visual feedback ensuring a real-time interactive control of locomotor performance; during second hour of treatment, during the second hour of treatment patients are treated according to conventional therapy consisting of exercises for passive and active mobilization of lower limbs, trunk control, standing, deambulation.
Device: Copernicis VF-Plus
Advanced gait training session with the addition of visual feedback ensuring a real-time interactive control of locomotor performance.
Active Comparator: Control group

Inpatients with a diagnosis of first-ever ischemic stroke in post acute phase, admitted for rehabilitation to S.Anna rehabilitation Institute.

The intervention consist of 2-h of rehabilitation daily sessions, five weekly over 6 weeks. During one hour of treatment, this group perform conventional therapy consisting of exercises for passive and active mobilization of lower limbs, trunk control, standing, deambulation; during second hour of treatment, during the second hour of treatment patients are treated according to conventional therapy consisting of exercises for passive and active mobilization of lower limbs, trunk control, standing, deambulation.
Other: Control group
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 6 weeks after the end of treatment
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).
up to 6 weeks after the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 weeks after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S.Anna Rehabilitation Institute

Investigators

  • Study Director: Paolo Tonin, MD, S.Anna Rehabilitation Insitute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISA COP062017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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