Stroke
Conditions
Keywords
Virtual Reality,, Enhanced Feedback,, Stroke,, Rehabilitation,, Motor Learning
Brief summary
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.
Detailed description
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).
Interventions
DEVICEEVER TEACHER
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.
DEVICENEVER TEACHER
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.
Sponsors
Società Italiana di Fisioterapia (SIF)
Ministry of Health, Italy
IRCCS San Camillo, Venezia, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Single blind randomized controlled trial (RCT)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* first single stroke, * absence of ideomotor apraxia, neglect, aphasia interfering with verbal comprehension, * 0 \< NIHSS-IT \< 4
Exclusion criteria
* bilateral or cerebellum stroke, * unstable medical conditions, * fracture, * major depressive disorders, * other neurological conditions, * epilepsy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Upper Extremity scale (FM UE) | Change from baseline FM UE scale at the end of Virtual therapy (four weeks thereafter) | Applied at the beginning and at the end of treatment (after 20 sessions). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment - Sensation | Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter) | Applied at the beginning and at the end of treatment (after 20 sessions). |
| Fugl-Meyer Assessment - Pain and ROM | Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter) | Applied at the beginning and at the end of treatment (after 20 sessions). |
| Reaching Performance Scale | Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter) | Applied at the beginning and at the end of treatment (after 20 sessions). |
| Functional Independence Measure scale (FIM) | Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter) | Applied at the beginning and at the end of treatment (after 20 sessions). |
| Nine Hole Pegboard Test | Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter) | Applied at the beginning and at the end of treatment (after 20 sessions). |
| Modified Ashworth Scale | Change from baseline of the Modified Ashworth scale at the end of Virtual therapy (four weeks thereafter) | Applied at the beginning and at the end of treatment (after 20 sessions). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Kinematic Assessment | Change from baseline of the following parameters; speed, time, peak at the end of Virtual therapy (four weeks thereafter) | 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. |
Countries
Italy
Outcome results
None listed