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| Name | Class |
|---|---|
| Ospedale Accreditato Villa Bellombra | UNKNOWN |
| Casa di Cura Città di Rovigo | UNKNOWN |
| IRCCS Centro Neurolesi Bonino Pulejo | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR group | Experimental | All participants will receive an hour of VR training 5 times/week for 4 weeks within the daily rehab routine. |
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| Control group | No Intervention | Participants will receive the usual rehabilitation activities due to their clinical needs (physical therapy, speech therapy, etc) for 5 times/week over 4 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in upper limb impairment | Motor recovery will be assessed through the Fugl Meyer Assessment - Upper Extremity | Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sofia Straudi, MD, PhD | Contact | +390532238720 | sofia.straudi@unife.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ferrara University Hospital | Recruiting | Ferrara | 44124 | Italy |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000080310 | Smart Glasses |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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Randomized Controlled Trial
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The randomization scheme will be generated using the website http://www.randomization.com and managed by an external administrator. The clinicians who will perform the outcome assessment will be blind regarding the subject's group.
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Patient's independence will be quantified with the Barthel Index |
| 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 | 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) | 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. | 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 | After 4 weeks |
| Embodiment | The embodiment feeling will be analyzed with the Gonzalez-Franco questionnaire | After 4 weeks |
| Cybersickness | For monitoring undesirable events the Simulator Sickness Questionnaire will be used | After 4 weeks |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |