Clinical trial NCT04364490: Rehabilitative Efficacy of a Visual Feedback Device for Locomotion of Post-stroke Patients
Official title: Study of the Rehabilitative Efficacy of Copernicus®, a Visual Feedback Device for the Early Start to Locomotion of Post-stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
Gait Rehabilitation
Visual feedback
sensor feedback
Lead sponsor: S.Anna Rehabilitation Institute
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 162
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After a stroke this ability may become worse or completely lost. It was demonstrated that hemiparetic patients with poor trunk function at admission stayed longer in a rehabilitation ward compared to patients who had better initial trunk function and could walk longer distances with speed at discharge. The reinforcement of trunk exercises in addition to conventional therapy seems to have a beneficial effect on erection station balance and locomotion in post-stroke patients. In the light of current knowledge, early verticalization and reinforcement of trunk exercises improve posture, balance and mobility. In this study, consecutive patients at first ischemic stroke (documented with TAC / RMN) will be evaluated. Patients in the study group will receive 60 minutes of conventional neuromotor rehabilitation treatment and 60 minutes of treatment with Copernicus®. The control group will receive 120 minutes of conventional neuro motor rehabilitation treatment.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To evaluate the effects of an early rehabilitation and deambulation treatment performed using a visual feedback device.
timeFrame: up to 6 weeks after the end of treatment
measure: To evaluate the effects of an early rehabilitation and deambulation treatment performed using a visual feedback device.
timeFrame: up to 6 weeks after the end of treatment
Secondary outcomes:
measure: To evaluate the effectiveness of a novel computerized BWS sensory feedback system (Copernicus®).
timeFrame: 6 weeks after the end of treatment
Other outcomes:
Locations:
city: Crotone
country: Italy
facility: S.Anna Institute
Study officials:
affiliation: S.Anna Rehabilitation Insitute
name: Paolo Tonin, MD
role: STUDY_DIRECTOR
References:
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