Stroke
Conditions
Keywords
stroke, Gait Rehabilitation, Visual feedback, sensor feedback
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.
Interventions
DEVICECopernicus noVF
Advanced gait training sessions by the computerized BWS system, named Copernicus®, without visual feedback.
DEVICECopernicis VF-Plus
Advanced gait training session with the addition of visual feedback ensuring a real-time interactive control of locomotor performance.
OTHERControl group
Usual care
Sponsors
S.Anna Rehabilitation Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Physicians (carrying out the clinical baseline assessment \[T0\] and post-treatment investigation \[T1\]), as well as, the primary researcher and data entry assistants were all blinded to the group membership of the patients.
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.
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effects of an early rehabilitation and deambulation treatment performed using a visual feedback device. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effectiveness of a novel computerized BWS sensory feedback system (Copernicus®). | 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). |
Countries
Italy
Outcome results
None listed