Multimodal Platform Combining VR and TENS for Stroke Rehabilitation
- Conditions
- Stroke
- Interventions
- Other: VR+TENSOther: Conventional rehabilitation
- Registration Number
- NCT06400823
- Lead Sponsor
- Institute Mihajlo Pupin
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Ischemic or haemorrhagic stroke patient
- At least 3 months after the stroke incident
- 10 <= FMUE <= 60 (motor function)
- Prior neurological or psychiatric disorders
- Severe cognitive impairment (MoCA score <10)
- Epilepsy
- Pacemakers or other electronic implants
- Unable to give an informed consent form
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VR+TENS VR+TENS Patients will undergo goal-oriented movements for upper-limb rehabilitation in a VR scenario. While performing the movement, patients will receive synchronous electrical stimulation targeting the medial nerve. The provided sensation will stimulate the interaction with elements in the virtual world. The intervention phase will last 3 weeks. Patients will undergo a minimum of three sessions per week (of around 60'). During each of these sessions, the first 10' will be employed for the calibration of the Transcutaneous Electrical Nerve Stimulation (TENS). In the remaining part of the session, subjects will perform some of the VR-based task-oriented games targeting different components. Conventional rehabilitation Conventional rehabilitation Patients in the control group will perform physical conventional rehabilitation provided by the rehabilitation clinic. The total amount of therapy will be the same as that of the VR+TENS group. The exercises will target the same components of the VR+TENS arm.
- Primary Outcome Measures
Name Time Method Changes in sensorimotor impairments 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) 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.
Changes in functional performances 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) 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.
Changes in body-representation metrics 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) 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
- Secondary Outcome Measures
Name Time Method Changes of spasticity indexes for shoulder, elbow and wrist 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) 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).
Changes in neuropathic pain perception 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) To quantify the experience of pain. This will be evaluated with Neuropathic Pain Symptom Inventory (The score goes from 0 to 100)
Changes in pain perception Every day, from day 1 to day 14; 5 weeks (2 weeks after the last rehabilitation session,T3) To quantify the experience of pain. This will be evaluated with Visual Analogue Scale. The score goes from 0 to 10.
Changes in degree of assistance required by an individual 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) 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).
Changes in peripersonal space 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) 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.
Treatment Satisfaction Measure 3 weeks (one day after the last rehabilitation session, T2) The subject marks on the treatment satisfaction on a Likert-scale.
Changes in tactile acuity 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) 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.
Changes in upper-limb mobility (velocity) Every day, from day 1 to day 14 To assess changes in velocity the investigators will measure kinematic velocity of the patients while performing rehabilitation tasks.
Changes in upper-limb mobility (smoothness) Every day, from day 1 to day 14 To assess changes in smoothness the investigators will measure kinematic smoothness of the patients while performing rehabilitation tasks.
Changes in upper-limb mobility (efficiency) Every day, from day 1 to day 14 To assess changes in efficiency the investigators will measure the amount and rate of task-oriented movements of the patients.
Changes in upper-limb mobility (precision) Every day, from day 1 to day 14 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.
Trial Locations
- Locations (1)
Clinic for rehabilitation dr Miroslav Zotovic
🇷🇸Belgrade, Serbia