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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Occupational Therapy | Active Comparator | 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. |
|
| Non-Immersive Virtual Reality Rehabilitation | Experimental | Description: 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Immersive Virtual Reality Rehabilitation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (FM-UE), Spanish-validated version (Ferrer B., 2015). This scale is widely used to evaluate motor recovery after stroke. Total scores range from 0 to 66, with higher scores indicating better motor function of the affected upper limb. The minimal clinically important difference (MCID) has been reported as 7.35 points. | Baseline and 3 months after baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (SF-12 Health Survey) | Quality of Life (Short Form-12 Health Survey, SF-12) Quality of life will be assessed using the Short Form-12 Health Survey (SF-12), which provides two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each component score ranges from 0 to 100, with higher scores indicating better perceived health status. | Baseline and 3 months after baseline. |
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Inclusion Criteria:
Participants must meet all of the following criteria:
Exclusion Criteria:
Participants will be excluded if any of the following conditions are present:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complutense University of Madrid | Madrid | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36959332 | Background | Hao J, He Z, Yu X, Remis A. Comparison of immersive and non-immersive virtual reality for upper extremity functional recovery in patients with stroke: a systematic review and network meta-analysis. Neurol Sci. 2023 Aug;44(8):2679-2697. doi: 10.1007/s10072-023-06742-8. Epub 2023 Mar 23. | |
| 34352269 | Background |
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De-identified individual participant data underlying the results reported in this study will be available upon reasonable request to the corresponding investigator. Data will be shared after de-identification in order to protect participant confidentiality and in accordance with applicable data protection regulations.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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Participants with chronic ischemic stroke of the dominant hemisphere middle cerebral artery will be randomly assigned using simple randomization implemented through REDCap to one of two parallel groups: (1) a non-immersive virtual reality rehabilitation program using the MindMotion⢠GO system, or (2) conventional occupational therapy according to standard clinical practice. Both groups will receive supervised rehabilitation sessions of equal duration and frequency (two sessions per week for seven weeks). Outcome assessments will be conducted at baseline and at follow-up by investigators blinded to treatment allocation.
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| Occupational Therapy | Behavioral | 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. |
|
| Emotional Status (Hospital Anxiety and Depression Scale - HADS) | Emotional status will be evaluated using the Hospital Anxiety and Depression Scale (HADS), a validated instrument designed to assess symptoms of anxiety and depression in clinical populations. The scale consists of two subscales (anxiety and depression), each ranging from 0 to 21, with higher scores indicating greater symptom severity. | Baseline and 3 months |
| Caregiver Burden (Zarit Burden Interview) | Caregiver burden will be assessed using the Zarit Burden Interview (ZBI), a validated instrument that measures the perceived burden experienced by caregivers of individuals with chronic conditions. Total scores range from 0 to 88, with higher scores indicating greater caregiver burden. | Baseline and 3 months after baseline. |
| Functional Impairment (Sheehan Disability Scale) | Functional impairment in work/school, social life, and family life will be evaluated using the Sheehan Disability Scale (SDS), a validated self-report instrument. The scale consists of three items, each scored from 0 to 10, yielding a total score ranging from 0 to 30, with higher scores indicating greater functional impairment. | Baseline and 3 months after baseline. |
| Hao J, Xie H, Harp K, Chen Z, Siu KC. Effects of Virtual Reality Intervention on Neural Plasticity in Stroke Rehabilitation: A Systematic Review. Arch Phys Med Rehabil. 2022 Mar;103(3):523-541. doi: 10.1016/j.apmr.2021.06.024. Epub 2021 Aug 2. |
| Background | Howard, M. C., Gutworth, M. B., & Jacobs, R. R. (2021). A meta-analysis of virtual reality training programs. Computers in Human Behavior, 121, 106808. https://doi.org/10.1016/j.chb.2021.106808 |
| 29656030 | Background | Das J, G K R. Post stroke depression: The sequelae of cerebral stroke. Neurosci Biobehav Rev. 2018 Jul;90:104-114. doi: 10.1016/j.neubiorev.2018.04.005. Epub 2018 Apr 12. |
| 31821799 | Background | Karamians R, Proffitt R, Kline D, Gauthier LV. Effectiveness of Virtual Reality- and Gaming-Based Interventions for Upper Extremity Rehabilitation Poststroke: A Meta-analysis. Arch Phys Med Rehabil. 2020 May;101(5):885-896. doi: 10.1016/j.apmr.2019.10.195. Epub 2019 Dec 7. |
| 40142592 | Background | Kenea CD, Abessa TG, Lamba D, Bonnechere B. Immersive Virtual Reality in Stroke Rehabilitation: A Systematic Review and Meta-Analysis of Its Efficacy in Upper Limb Recovery. J Clin Med. 2025 Mar 7;14(6):1783. doi: 10.3390/jcm14061783. |
| 40537150 | Background | Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Chapman M, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2025 Jun 20;6(6):CD008349. doi: 10.1002/14651858.CD008349.pub5. |
| 31317037 | Background | Lee HS, Park YJ, Park SW. The Effects of Virtual Reality Training on Function in Chronic Stroke Patients: A Systematic Review and Meta-Analysis. Biomed Res Int. 2019 Jun 18;2019:7595639. doi: 10.1155/2019/7595639. eCollection 2019. |
| 20544413 | Background | Martin-Carrasco M, Otermin P, Perez-Camo V, Pujol J, Aguera L, Martin MJ, Gobartt AL, Pons S, Balana M. EDUCA study: Psychometric properties of the Spanish version of the Zarit Caregiver Burden Scale. Aging Ment Health. 2010 Aug;14(6):705-11. doi: 10.1080/13607860903586094. |
| 33442915 | Background | Mekbib DB, Debeli DK, Zhang L, Fang S, Shao Y, Yang W, Han J, Jiang H, Zhu J, Zhao Z, Cheng R, Ye X, Zhang J, Xu D. A novel fully immersive virtual reality environment for upper extremity rehabilitation in patients with stroke. Ann N Y Acad Sci. 2021 Jun;1493(1):75-89. doi: 10.1111/nyas.14554. Epub 2021 Jan 14. |
| Background | Ministerio de Sanidad. (2024). Estrategia en Ictus del Sistema Nacional de Salud. Actualización 2024. MINISTERIO DE SANIDAD CENTRO DE PUBLICACIONES. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.sanidad.gob.es/areas/calidadAsistencial/estrategias/ictus/docs/Estrategia_en_Ictus_del_SNS._Actualizacion_2024_accesible.pdf |
| 23436325 | Background | Negyessy L, Palfi E, Ashaber M, Palmer C, Jakli B, Friedman RM, Chen LM, Roe AW. Intrinsic horizontal connections process global tactile features in the primary somatosensory cortex: neuroanatomical evidence. J Comp Neurol. 2013 Aug 15;521(12):2798-817. doi: 10.1002/cne.23317. |
| 40269877 | Background | Olana DD, Abessa TG, Lamba D, Triccas LT, Bonnechere B. Effect of virtual reality-based upper limb training on activity of daily living and quality of life among stroke survivors: a systematic review and meta-analysis. J Neuroeng Rehabil. 2025 Apr 24;22(1):92. doi: 10.1186/s12984-025-01603-1. |
| 25387001 | Background | Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, van Wijck F. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014 Nov 12;2014(11):CD010820. doi: 10.1002/14651858.CD010820.pub2. |
| 12580829 | Background | Quintana JM, Padierna A, Esteban C, Arostegui I, Bilbao A, Ruiz I. Evaluation of the psychometric characteristics of the Spanish version of the Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 2003 Mar;107(3):216-21. doi: 10.1034/j.1600-0447.2003.00062.x. |
| 15193779 | Background | Schaechter JD. Motor rehabilitation and brain plasticity after hemiparetic stroke. Prog Neurobiol. 2004 May;73(1):61-72. doi: 10.1016/j.pneurobio.2004.04.001. |
| 19376156 | Background | Serino A, Haggard P. Touch and the body. Neurosci Biobehav Rev. 2010 Feb;34(2):224-36. doi: 10.1016/j.neubiorev.2009.04.004. Epub 2009 Apr 17. |
| 38790042 | Background | Soleimani M, Ghazisaeedi M, Heydari S. The efficacy of virtual reality for upper limb rehabilitation in stroke patients: a systematic review and meta-analysis. BMC Med Inform Decis Mak. 2024 May 24;24(1):135. doi: 10.1186/s12911-024-02534-y. |
| 16271575 | Background | Jang SH, You SH, Hallett M, Cho YW, Park CM, Cho SH, Lee HY, Kim TH. Cortical reorganization and associated functional motor recovery after virtual reality in patients with chronic stroke: an experimenter-blind preliminary study. Arch Phys Med Rehabil. 2005 Nov;86(11):2218-23. doi: 10.1016/j.apmr.2005.04.015. |
| 18570798 | Background | Vilagut G, Valderas JM, Ferrer M, Garin O, Lopez-Garcia E, Alonso J. [Interpretation of SF-36 and SF-12 questionnaires in Spain: physical and mental components]. Med Clin (Barc). 2008 May 24;130(19):726-35. doi: 10.1157/13121076. Spanish. |
| 29853839 | Background | Zhang JJQ, Fong KNK, Welage N, Liu KPY. The Activation of the Mirror Neuron System during Action Observation and Action Execution with Mirror Visual Feedback in Stroke: A Systematic Review. Neural Plast. 2018 Apr 24;2018:2321045. doi: 10.1155/2018/2321045. eCollection 2018. |
| 40236896 | Background | Zhang J, Liu M, Yue J, Yang J, Xiao Y, Yang J, Cai E. Effects of virtual reality with different modalities on upper limb recovery: a systematic review and network meta-analysis on optimizing stroke rehabilitation. Front Neurol. 2025 Apr 1;16:1544135. doi: 10.3389/fneur.2025.1544135. eCollection 2025. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |