Virtual Reality (VR) Platform and Transcutaneous Electrical Nerve Stimulation (TENS) for Early Stroke Rehabilitation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Medical University of Vienna
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Changes in functional performances
Study Overview
Brief Summary
Stroke is one of the leading causes of disability, leaving millions of individuals each year impaired with lasting motor and sensory impairments. In the subacute phase, which goes from the first week to 3 months post-stroke, the patient has the highest recovery, which could be boosted by proper technologies intended for the rehabilitation of the patients. The impairments that the patients experience are extremely heterogeneous and go from muscle weakness to spasticity of the paretic side of the body. Beyond motor deficits, stroke survivors also suffer from sensory impairment (they do not properly feel with the paretic side of their body), impaired body representation (misjudging the size, position, and movement of their affected limb), which can further hinder recovery.
Traditional rehabilitation primarily targets motor function, often without considering at all the role of sensory feedback and body perception in the recovery process. However, growing evidence suggests that the combination of multiple sensory modalities towards a multifaceted rehabilitation can enhance neuroplasticity and improve rehabilitation outcomes.
To address this, the investigators have developed a novel rehabilitation approach that integrates immersive virtual reality (VR) with transcutaneous electrical nerve stimulation (TENS). This system allows stroke patients to interact with a virtual environment while receiving synchronized tactile stimulation, reinforcing sensorimotor integration. Unlike conventional therapy, which relies on passive or repetitive exercises, this approach engages patients in active, goal-oriented movements, tailored to their individual recovery progress.
By focusing on the subacute stroke population, this project aims to leverage the brain's heightened plasticity during early recovery to maximize functional improvements. The VR-based intervention will adapt to each patient's motor abilities, providing real-time feedback to encourage precise movements and enhance sensory processing. Through this multisensory experience, the investigators seek to improve not only motor control but also sensory and body representation measures.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed diagnosis of ischemic or hemorrhagic stroke
- •In the subacute phase (from 7 days to 3 months from last stroke onset)
- •Fugl-Meyer-Upper Extremity (FMUE) scale for the motor part: FMUE ≥ 10
- •Ability to sit in an upright position
- •Age between 18 and 80 years
Exclusion Criteria
- •Other neurological or physical impairment or mental condition that, in the judgment of the investigator, does not allow participation in the study.
- •Mini-Mental State Examination (MMSE) < 24
- •Nausea, headaches or fatigue due to VR-generated environment ("virtual reality motion sickness")
- •Peripheral nerve damage in the affected arm or hand
- •Pacemaker or other electronic implants
Arms & Interventions
Conventional Rehabilitation
Participants will undergo the same therapy duration, engaging in conventional physiotherapy, occupational therapy, or physical therapy. Exercises and movements will be designed to align with those in the experimental group.
Intervention: Conventional rehabilitation (Other)
VR+TENS
Patients will engage in goal-directed upper-limb rehabilitation exercises within a virtual reality environment. During these exercises, they will receive synchronized electrical stimulation targeting the median nerve.
The intervention phase will span three weeks, with patients participating in at least three sessions per week, each lasting approximately 60 minutes.
Intervention: VR+TENS (Other)
Outcomes
Primary Outcomes
Changes in functional performances
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)
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 sensorimotor impairments
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)
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 upper limb body representation
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)
To measure the body representation of the subjects the investigators will use body-landmark metric. In VR, the subject is asked to locate the position of specific body landmarks (e.g. elbow, inner wrist, outer wrist, index, ring) describing the proportion of patients' arm while a black panel is on top of his/her arm. The investigators will then compare the real and perceived dimension of patients' arm
Secondary Outcomes
- Changes in upper limb kinematics (Efficiency)(Every day, from day 1 to day 14)
- Changes in degree of assistance required(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 spasticity at hand and elbow level(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(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 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))
- Changes in spatial neglect (CBS)(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 spatial neglect (LBT)(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 kinematics (Velocity)(Every day, from day 1 to day 14)
- Changes in upper limb kinematics (Smoothness)(Every day, from day 1 to day 14)
- Changes in upper limb kinematics (Precision)(Every day, from day 1 to day 14)
Investigators
Prof. Stanisa Raspopovic
Professor
Medical University of Vienna