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| Name | Class |
|---|---|
| Società Italiana di Fisioterapia (SIF) | UNKNOWN |
| Ministry of Health, Italy | OTHER_GOV |
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The aim of the project is to assess whether the continuous visualization of on-line teacher in virtual reality (VR) is effective for the improvement of upper limb motor function, in stroke patients.
A single-blind randomized controlled trial (RCT) will be carried out to compare the effects of reinforced feedback in virtual environment (RFVE) treatment with continuous displaying of a virtual teacher (EVER TEACHER group) with RFVE without the presence of a virtual teacher (NEVER TEACHER group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVER TEACHER | Experimental | In EVER TEACHER group a specific feedback called "virtual teacher" will be displayed. The virtual teacher perform the correct movement to emulate, that is supposed to stimulate the motor adaptation exploiting a supervised learning mechanism. This feedback will give an on-line information on motor performance quality, allowing a real time visual comparison between patient's own execution and teacher one. During the experiment, patients will receive 1 hour of virtual reality-based therapy and the treatment will last 1 hour a day, five days weekly for four weeks. |
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| NEVER TEACHER | Other | In NEVER TEACHER group the subjects will be asked to perform the same exercises with the upper limb without the virtual teacher assistance. The treatment will last four weeks with daily sessions of 60 minutes, five times per week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVER TEACHER | Device | The treatment will be performed in a darkened room, to avoid distraction provided by environmental stimuli. The patients will be seat on a standard chair in front of a wall screen handling a sensorized object with plegic hand. In case of grasping deficits the hand's surface will be used as end effector (i.e. sensorized glove worn by the patient). During the treatment a specific feedback called "virtual teacher" will be displayed. The Reinforced Feedback in Virtual Environment (RFVE) approach consists of performing different motor tasks moving the end effector simultaneously displayed in the virtual scenario. The Virtual Reality Rehabilitation System (VRRS®. Khymeia Group, Noventa Padovana. Italy) will be used as device to provide the artificial environment. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Upper Extremity scale (FM UE) | Applied at the beginning and at the end of treatment (after 20 sessions). | Change from baseline FM UE scale at the end of Virtual therapy (four weeks thereafter) |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment - Sensation | Applied at the beginning and at the end of treatment (after 20 sessions). | Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter) |
| Fugl-Meyer Assessment - Pain and ROM |
| Measure | Description | Time Frame |
|---|---|---|
| Kinematic Assessment | The kinematic assessment include the execution of standardised upper limb movements, such as: forearm pronation and supination, elbow flexion and extension, shoulder abduction and adduction, shoulder internal and external rotation, shoulder flexion and extension and reaching movements. The mean linear velocity (Speed), the mean duration of movements (Time) and the mean number of submovements (Peak) will be measured, by means of the Virtual Reality Rehabilitation System (VRRS®. Khymeia Group, Noventa Padovana. Italy). The data will be registered at the beginning and at the end of treatment, 4 weeks thereafter. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Turolla, PhD | San Camillo IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Camillo IRCCS | Venezia | VE | 30126 | Italy | ||
| Azienda ULSS 3 Serenissima |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23914733 | Background | Turolla A, Dam M, Ventura L, Tonin P, Agostini M, Zucconi C, Kiper P, Cagnin A, Piron L. Virtual reality for the rehabilitation of the upper limb motor function after stroke: a prospective controlled trial. J Neuroeng Rehabil. 2013 Aug 1;10:85. doi: 10.1186/1743-0003-10-85. | |
| 24745024 | Background | Kiper P, Agostini M, Luque-Moreno C, Tonin P, Turolla A. Reinforced feedback in virtual environment for rehabilitation of upper extremity dysfunction after stroke: preliminary data from a randomized controlled trial. Biomed Res Int. 2014;2014:752128. doi: 10.1155/2014/752128. Epub 2014 Mar 13. |
| Label | URL |
|---|---|
| Italian Society for Physiotherapy (Società Italiana di Fisioterapia) | View source |
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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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Single blind randomized controlled trial (RCT)
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| NEVER TEACHER | Device | The patients allocated to NEVER TEACHER group, will be treated using the VRRS and the proceedings will be the same as described for experimental group. In this group, the patient will move the real object (e.g. ball) following the trajectory of the corresponding virtual object displayed on the wall screen in accordance with the requested virtual task and without the 'virtual teacher' support. |
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Applied at the beginning and at the end of treatment (after 20 sessions). |
| Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter) |
| Reaching Performance Scale | Applied at the beginning and at the end of treatment (after 20 sessions). | Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter) |
| Modified Ashworth Scale | Applied at the beginning and at the end of treatment (after 20 sessions). | Change from baseline of the Modified Ashworth scale at the end of Virtual therapy (four weeks thereafter) |
| Functional Independence Measure scale (FIM) | Applied at the beginning and at the end of treatment (after 20 sessions). | Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter) |
| Nine Hole Pegboard Test | Applied at the beginning and at the end of treatment (after 20 sessions). | Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter) |
| Change from baseline of the following parameters; speed, time, peak at the end of Virtual therapy (four weeks thereafter) |
| Venice |
| 30126 |
| Italy |
| Background | Zucconi C, Valt V, Agostini M, Turolla A, Tonin P, Piron L. Assessment of a virtual teacher feedback for the recovery of the upper limb after stroke. Italian Journal of Physiotherapy 2011;1(4):101-6. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |