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

NCT ID: NCT04364490

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Copernicus noVF

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Copernicis VF-Plus

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

Usual care

Interventions

Copernicus noVF

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

Intervention Type: DEVICE

Copernicis VF-Plus

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

Intervention Type: DEVICE

Control group

Usual care

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S.Anna Rehabilitation Institute

OTHER

Sponsor Role: lead

Responsible Party

Loris Pignolo

Biomedical Engineer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Tonin, MD

Role: STUDY_DIRECTOR

S.Anna Rehabilitation Insitute

Locations

S.Anna Institute

Crotone, , Italy

Countries

Italy

References

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Pignolo L, Serra S, Basta G, Carozzo S, Arcuri F, Pignataro LM, Ciancarelli I, Tonin P, Cerasa A. Data on a new neurorehabilitation approach targeting functional recovery in stroke patients. Data Brief. 2019 Oct 28;27:104685. doi: 10.1016/j.dib.2019.104685. eCollection 2019 Dec.

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Other Identifiers

ISA COP062017

Identifier Type: -

Identifier Source: org_study_id