Rehabilitative Efficacy of a Visual Feedback Device for Locomotion of Post-stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

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.
    

Intervention name(s): Copernicus noVF; Copernicis VF-Plus; Control group
Intervention type(s): Device; Device; Other
Intervention description(s): Advanced gait training sessions by the computerized BWS system, named Copernicus®, without visual feedback.; Advanced gait training session with the addition of visual feedback ensuring a real-time interactive control of locomotor performance.; Usual care
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: stroke; Gait Rehabilitation; Visual feedback; sensor feedback