Virtual Reality-Based Upper Limb Rehabilitation in Chronic Stroke: A Randomized Trial

Universidad Complutense de Madrid26 enrolled

Overview

This randomized controlled study aims to evaluate the effectiveness of non-immersive virtual reality-based rehabilitation using the MindMotion™ GO system compared with conventional occupational therapy for improving upper limb motor function in individuals with chronic stroke. Stroke is a leading cause of long-term disability in adults worldwide, and barriers such as limited access to rehabilitation services, low motivation, and reduced adherence may hinder recovery in the chronic phase. Participants will be randomly assigned to either an experimental group receiving non-immersive virtual reality training or a control group receiving conventional occupational therapy according to standard clinical practice. Both groups will complete two rehabilitation sessions per week for eight weeks, with each session lasting approximately 40 minutes. The study will assess upper limb motor function, performance in activities of daily living, and quality of life. In addition, electroencephalography (EEG) will be used before and after the intervention to explore potential neuroplastic changes associated with rehabilitation. Outcome assessments will be conducted at baseline and at follow-up approximately three months after the initial evaluation. The results of this study may help determine whether non-immersive virtual reality is an effective and accessible tool to enhance rehabilitation outcomes in individuals with chronic stroke.

Stroke is one of the leading causes of death and long-term disability worldwide and represents a major public health challenge. Many individuals who survive a stroke experience persistent motor impairments, particularly affecting upper limb function, which significantly limits independence in activities of daily living and reduces quality of life. In the chronic phase of stroke, access to intensive rehabilitation programs may be limited by several barriers, including reduced availability of services, high costs, transportation difficulties, low motivation, and lack of social support. Virtual reality (VR)-based rehabilitation has emerged as a promising therapeutic approach to enhance engagement, increase therapy intensity, and potentially improve functional outcomes in neurological rehabilitation. Non-immersive virtual reality systems allow patients to interact with simulated environments through computer interfaces while performing goal-directed motor tasks. These systems may provide real-time feedback, increase motivation, and promote repetitive, task-oriented practice that supports motor learning and neuroplasticity. The present study is a randomized controlled trial designed to evaluate the effectiveness of non-immersive virtual reality-based rehabilitation using the MindMotion™ GO system compared with conventional occupational therapy in individuals with chronic stroke affecting the middle cerebral artery territory. Participants who meet the inclusion criteria will be randomly assigned to one of two groups: Experimental group: Participants will receive rehabilitation using the non-immersive virtual reality platform MindMotion™ GO. Training sessions will be performed under the supervision of a researcher and will consist of task-oriented exercises within a virtual environment designed to stimulate upper limb movements and functional activities. Control group: Participants will receive conventional occupational therapy according to standard clinical practice. Therapy sessions will include therapist-guided task-oriented exercises aimed at improving upper limb function. Both groups will complete two rehabilitation sessions per week for eight weeks (16 sessions in total). Each session will last approximately 40 minutes, including short rest periods during training. Participants will undergo baseline evaluation including clinical assessment and electroencephalography (EEG) recording in resting-state and task conditions. Functional outcomes will be evaluated using standardized clinical scales assessing upper limb motor function, activities of daily living, and quality of life. After completion of the intervention, participants will undergo follow-up assessments approximately three months after the baseline visit, including repeat EEG recordings to explore potential neuroplastic changes associated with the rehabilitation intervention. The results of this study will contribute to understanding whether non-immersive virtual reality-based rehabilitation can improve functional recovery and promote neuroplasticity in individuals with chronic stroke.

Interventions

Non-Immersive Virtual Reality RehabilitationBEHAVIORAL

Participants assigned to the experimental group will receive upper limb rehabilitation using a non-immersive virtual reality platform (MindMotion™ GO). Training will consist of task-oriented exercises performed within interactive virtual environments designed to promote active movements of the affected upper limb and facilitate motor learning through real-time visual and auditory feedback. Sessions will be performed under the supervision of a member of the research team. Participants will attend two sessions per week for seven weeks, with each session lasting approximately 40 minutes and including short rest periods as needed. The total number and duration of sessions will be equivalent to those provided in the control group receiving conventional occupational therapy.

Occupational TherapyBEHAVIORAL

Arm Description: Participants assigned to the control group will receive conventional occupational therapy according to standard clinical practice for upper limb rehabilitation after stroke. Therapy sessions will be supervised by an experienced occupational therapist and will consist of task-oriented exercises aimed at improving motor function, coordination, and functional use of the affected upper limb in activities of daily living. Sessions will be conducted twice per week for seven weeks, with each session lasting approximately 40 minutes and including short rest periods as needed. The number of sessions, duration, and intensity of therapy will be equivalent to those provided in the experimental virtual reality group.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants must meet all of the following criteria: Age between 18 and 80 years. Chronic phase of ischemic stroke affecting the dominant hemisphere in the Middle Cerebral Artery territory (more than 6 months and less than 4 years since stroke onset). Ability to actively extend the wrist at least 20 degrees and extend the fingers at least 10 degrees. Upper limb muscle strength of the paretic limb ≥2 in the shoulder, elbow, and wrist. Adequate trunk control. Adequate vision and hearing to interact with the rehabilitation platform. Ability to collaborate and follow study procedures. Meeting safety criteria for Electroencephalography recording. Signed informed consent. Exclusion Criteria: Participants will be excluded if any of the following conditions are present: Severe cognitive impairment (Montreal Cognitive Assessment score \<10). Major depression or emotional disorders associated with severe attention or cooperation deficits that may interfere with hand function. Severe psychiatric disease. Severe spasticity in the affected limb (Modified Modified Ashworth Scale ≥3-4). Aphasia preventing comprehension of verbal instructions. Visuospatial neglect preventing interaction with the rehabilitation interface. Participation in other upper limb rehabilitation therapies during the study period. Severe functional dependency prior to stroke. History of other strokes occurring after the index stroke. Any medical condition that, in the opinion of the investigator, could interfere with study participation or data interpretation. \-

Outcomes

Primary Outcomes

Upper Limb Motor Function

Upper Limb Motor Function (Fugl-Meyer Assessment - Upper Extremity, FM-UE) Change in upper limb motor function will be assessed using the Fugl-Meyer Assessment Upper Extremity, a validated scale widely used to evaluate motor recovery after stroke. The scale ranges from 0 to 66 points, with higher scores indicating better motor function of the affected upper limb.

Time frame: Baseline and 3 months after baseline.

Secondary Outcomes

Quality of Life (SF-12 Health Survey)

Quality of life will be assessed using the Short Form-12 Health Survey, which evaluates physical and mental health components. Higher scores indicate better perceived health status.

Time frame: Baseline and 3 months after baseline.

Emotional Status (Hospital Anxiety and Depression Scale - HADS)

Emotional status will be evaluated using the Hospital Anxiety and Depression Scale, which measures symptoms of anxiety and depression in clinical populations.

Time frame: Baseline and 3 mon

Caregiver Burden (Zarit Burden Interview)

Caregiver burden will be assessed using the Zarit Burden Interview, which measures the perceived burden experienced by caregivers of patients with chronic conditions.

Time frame: Baseline and 3 months after base

Functional Impairment (Sheehan Disability Scale)

Functional impairment in work, social life, and family life will be evaluated using the Sheehan Disability Scale.

Time frame: Baseline and 3 months after baseline.

Virtual Reality-Based Upper Limb Rehabilitation in Chronic Stroke: A Randomized Trial

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes