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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Four 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.
Ferrara University Hospital
Ferrara, Italy
RECRUITINGChanges in upper limb impairment
Motor recovery will be assessed through the Fugl Meyer Assessment - Upper Extremity
Time frame: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)
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
Time frame: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)
Change in Activities of Daily Living
Patient's independence will be quantified with the Barthel Index
Time frame: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)
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
Time frame: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)
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)
Time frame: Parameters changes (e.g. hand peak velocities) before (T0) and after (T1) the 4 weeks of treatment
Electroencephalogram
The EEG signals will be measured by means of a 32-channel cap, according to the International 10-20 system, recorded and monitored by computerized devices.
Time frame: Data changes before (T0) and after (T1) the 4 weeks of treatment (4 weeks) and at 6-month follow-up (T2)
Treatment satisfaction
The satisfaction related to the virtual training will be investigated through a specific questionnaire
Time frame: After 4 weeks
Embodiment
The embodiment feeling will be analyzed with the Gonzalez-Franco questionnaire
Time frame: After 4 weeks
Cybersickness
For monitoring undesirable events the Simulator Sickness Questionnaire will be used
Time frame: After 4 weeks
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