About this trial
Stroke produces brain damages that results in sensory, motor, and cognitive impairments which reduce the patient's quality of life and social participation. Upper limb recovery is a complex process whose goal is to allow the patients to gain, in part or completely, independence in daily living activities, for that it represents one of the most important rehabilitation focus. Virtual reality is a fairly recent approach able to simulate concrete movements and functional tasks in a higher dosage compared to other therapies. It seems that the use of VR could improve limb function, however, the amount of this gain is still unclear because of insufficient evidence. This study aims at quantitatively investigating the effectiveness of an HMD immersive virtual reality system on the upper limb functioning in subacute stroke survivors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of first, ischemic or hemorrhagic, stroke verified by brain imaging within 4 week
upper limb motor impairment defined by an upper extremity score <55 on the Fugl-Meyer Assessment
Disqualifiers
neurological conditions in addition to stroke that may affect motor function
other medical conditions likely to interfere with the ability to safely complete the study protocol
impaired cognitive functioning that influences the ability to give informed consent
severe neuropsychological disorders
Trial design
Parallel
Treatments tested in this trial
Virtual Reality
DeviceFour tasks, uni and bi-manuals, will be proposed for the treatment of the patient's paretic upper limb in virtual-apartment for improving the relevance and the transferability of the movements requested.
Treatment groups
Trial outcomes
Primary outcomes
Changes in upper limb impairment
Motor recovery will be assessed through the Fugl Meyer Assessment - Upper Extremity
Secondary outcomes
Change in Spasticity
Spasticity grade at the paretic upper limb will be measured with the Ashworth Scale (0-5), in which higher scores are related to more severe muscle hypertonia
Change in Activities of Daily Living
Patient's independence will be quantified with the Barthel Index
Change in perceived quality of life
Stroke Impact Scale 2.0 will be performed for investigating the perceived quality of life, higher scores indicate better quality of life perceived
Kinematic data
Instrumental data of hand movements registered during the sessions (relevant kinematic indexes will be recorded and offline analyzed such as hand trajectories and peak velocity)
Sponsors and contacts
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University Hospital of Ferrara
Lead sponsor
Ospedale Accreditato Villa Bellombra
Collaborator
Casa di Cura Città di Rovigo
Collaborator
IRCCS Centro Neurolesi Bonino Pulejo
Collaborator