Stroke is a disabling medical condition annually affecting up to 15 million people worldwide. It leads to upper-limb impairments encompassing motor and sensory deficits together with cognitive self-body and space misrepresentation, overall limiting the functional independence of 70% of stroke survivors. On the motor side, stroke could account for hemiparesis (weakness or paralysis affecting the side contralateral to the brain lesion), muscle weakness, spasticity, loss of coordination, and others. On the sensory side, especially in the first stages after the stroke occurs, stroke could account for sensory loss, with the patient not being able to perceive what he's touching with the impaired arm.On a cognitive level, it has been shown that chronic stroke patients have distorted body representation and space representation. They perceive their impaired arm as shorter and the impaired hand as larger. Despite initial evidence of the crucial role of sensory-motor integration toward a restored body representation to promote effective rehabilitation, conventional approaches suffer from the bias of prioritizing motor recovery, while disregarding stroke-induced sensory and body representation deficits. In this view, the creation of a virtual reality (VR) scenario in which the person is fully immersed, could potentially play a significant role in improving stroke patients' rehabilitation. Taking this into consideration, this project aims to assess whether a multimodal platform combining VR with TENS inducing full-body illusion toward a virtual avatar could positively impact motor performances, sensory assessments, and self-body and space representation of stroke patients. More into detail, the intervention will consist of the patient performing some task-oriented movement within the virtual reality and congruently tactile receiving feedback through transcutaneous electrical nerve stimulation. The subject will receive clear instruction within the virtual reality scenario to perform specific actions toward a final goal. These actions will be designed to make the subject repeat some crucial movements in their rehabilitation process. Depending on the motor impairment of the patient, the investigators will adapt the characteristics and the difficulty of the task accordingly.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
During the invention, patients will be in VR scenarios and play task-oriented games, interacting with elements that appear in the virtual world, to improve mobility and functional independence of the upper limbs. The task-oriented games will target different components depending on the disability of the patient.
Patients will perform conventional upper-limb stroke rehabilitation. The movement performed will be comparable with the movement performed in the VR+TENS group
Clinic for rehabilitation dr Miroslav Zotovic
Belgrade, Serbia
RECRUITINGChanges in sensorimotor impairments
To assess the sensorimotor impairment in individuals who have had a stroke the investigators will use Fugl-Meyer for upper extremity (FMUE). FMUE assesses reflex activity, movement control, muscle strength, and sensory performances. It comprises items scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully.
Time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in functional performances
To assess functional performance of the upper extremity through observational means the investigators will use the Action Research Arm Test (ARAT). The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). The total score goes from 0 to 57. Performance on each item is rated on a 4-point ordinal scale ranging from: 3) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1) Performs test partially 0) Can perform no part of test.
Time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in body-representation metrics
To measure the body representation of the subjects the investigators will use body-landmark metrics. In VR, the subject is asked to locate the position of specific body landmarks (e.g. elbow, inner wrist, outer wrist, index, ring) while a black panel is on top of his/her arm. The investigators will then compare the real and perceived dimensions of patients' arms and hands
Time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in degree of assistance required by an individual
To assess the degree of assistance required by an individual on ten mobility and self-care the investigators will use the Barthel Index. The score goes from 0 to 100. It consists of an ordinal scale which measures a person's ability to complete activities of daily living (ADL).
Time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in peripersonal space
To measure the peri-personal space of stroke patients (the space in which multisensory integration is enhanced). Test Performance: In VR, the subject is sitting on a table and sees balls approaching him. He/she's asked to press a controller whenever he/she feels electrical stimulation.
Time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes of spasticity indexes for shoulder, elbow and wrist
The investigators will use Ashworth Scale to test resistance to passive movement about a joint with varying degrees of velocity. This test is performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension (the point at which the first soft resistance is met).
Time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in pain perception
To quantify the experience of pain. This will be evaluated with Visual Analogue Scale. The score goes from 0 to 10.
Time frame: Every day, from day 1 to day 14; 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in neuropathic pain perception
To quantify the experience of pain. This will be evaluated with Neuropathic Pain Symptom Inventory (The score goes from 0 to 100)
Time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Treatment Satisfaction Measure
The subject marks on the treatment satisfaction on a Likert-scale.
Time frame: 3 weeks (one day after the last rehabilitation session, T2)
Changes in tactile acuity
To measure the tactile acuity of patients we will use the Two-Point discrimination test. While blindfolded, the patient is repetitively touched with either one or two pins (fixed distance) and he asked to tell how many pins he/she feels.
Time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in upper-limb mobility (velocity)
To assess changes in velocity the investigators will measure kinematic velocity of the patients while performing rehabilitation tasks.
Time frame: Every day, from day 1 to day 14
Changes in upper-limb mobility (smoothness)
To assess changes in smoothness the investigators will measure kinematic smoothness of the patients while performing rehabilitation tasks.
Time frame: Every day, from day 1 to day 14
Changes in upper-limb mobility (efficiency)
To assess changes in efficiency the investigators will measure the amount and rate of task-oriented movements of the patients.
Time frame: Every day, from day 1 to day 14
Changes in upper-limb mobility (precision)
To assess changes in precision the investigators will measure the spatial precision (error with respect to a predefined correct movement) during the task-oriented movements of the patient.
Time frame: Every day, from day 1 to day 14
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