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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
124
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.
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.
San Camillo IRCCS
Venezia, VE, Italy
Azienda ULSS 3 Serenissima
Venice, Italy
Fugl-Meyer Upper Extremity scale (FM UE)
Applied at the beginning and at the end of treatment (after 20 sessions).
Time frame: Change from baseline FM UE scale at the end of Virtual therapy (four weeks thereafter)
Fugl-Meyer Assessment - Sensation
Applied at the beginning and at the end of treatment (after 20 sessions).
Time frame: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
Fugl-Meyer Assessment - Pain and ROM
Applied at the beginning and at the end of treatment (after 20 sessions).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)
Nine Hole Pegboard Test
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Applied at the beginning and at the end of treatment (after 20 sessions).
Time frame: Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)