- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07534124
Virtual Reality-Based Upper Limb Rehabilitation in Chronic Stroke
Non-Immersive Virtual Reality (MindMotion™ GO) Improves Upper Limb Motor Function in Chronic Left MCA Stroke: A Randomized Controlled Trial
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Madrid, Madrid, Spain
- Complutense University of Madrid
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Occupational Therapy
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. |
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.
|
|
Experimental: Non-Immersive Virtual Reality Rehabilitation
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper Limb Motor Function
Time Frame: Baseline and 3 months after baseline.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life (SF-12 Health Survey)
Time Frame: Baseline and 3 months after baseline.
|
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.
|
|
Emotional Status (Hospital Anxiety and Depression Scale - HADS)
Time Frame: Baseline and 3 months
|
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)
Time Frame: Baseline and 3 months after baseline.
|
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)
Time Frame: Baseline and 3 months after baseline.
|
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.
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Kenea, C. D., Abessa, T. G., Lamba, D., & Bonnechère, B. (2025). Immersive Virtual Reality in Stroke Rehabilitation: A Systematic Review and Meta-Analysis of Its Efficacy in Upper Limb Recovery. Journal of Clinical Medicine, 14(6), 1783. https://doi.org/10.3390/jcm14061783
- Hao, J., He, Z., Yu, X., & Remis, A. (2023). Comparison of immersive and non-immersive virtual reality for upper extremity functional recovery in patients with stroke: A systematic review and network meta-analysis. Neurological Sciences, 44(8), 2679-2697. https://doi.org/10.1007/s10072-023-06742-8
- Hao, J., Xie, H., Harp, K., Chen, Z., & Siu, K. C. (2022). Effects of Virtual Reality Intervention on Neural Plasticity in Stroke Rehabilitation: A Systematic Review. In Archives of Physical Medicine and Rehabilitation (Vol. 103, Issue 3). https://doi.org/10.1016/j.apmr.2021.06.024
- 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
- Jyotirekha, D., & Rajanikant, G. K. (2018). Post stroke depression: The sequelae of cerebral stroke. 90, 104-114. https://doi.org/10.1016/j.neubiorev.2018.04.005
- Karamians, R., Proffitt, R., Kline, D., & Gauthier, L. V. (2020b). Effectiveness of Virtual Reality- and Gaming-Based Interventions for Upper Extremity Rehabilitation Poststroke: A Meta-analysis. Archives of Physical Medicine and Rehabilitation, 101(5), 885-896. https://doi.org/10.1016/j.apmr.2019.10.195
- Laver, K. E., Lange, B., George, S., Deutsch, J. E., Saposnik, G., Chapman, M., & Crotty, M. (2025). Virtual reality for stroke rehabilitation. Cochrane Database of Systematic Reviews, 2025(6). https://doi.org/10.1002/14651858.CD008349.pub5
- Lee, H. S., Park, Y. J., & Park, S. W. (2019). The Effects of Virtual Reality Training on Function in Chronic Stroke Patients: A Systematic Review and Meta-Analysis. BioMed Research International, 2019, 1-12. https://doi.org/10.1155/2019/7595639
- Martin-Carrasco, M., Otermin, P., & Pérez-Camo, J. (2020). EDUCA study: Psychometric properties of the Spanish version of the Zarit Caregiver Burden Scale. 14(6), 705-711. https://doi.org/doi: 10.1080/13607860903586094.
- Mekbib, D. B., Debeli, D. K., Zhang, L., Fang, S., Shao, Y., Yang, W., Han, J., Jiang, H., Zhu, J., Zhao, Z., Cheng, R., Ye, X., Zhang, J., & Xu, D. (2021). A novel fully immersive virtual reality environment for upper extremity rehabilitation in patients with stroke. Annals of the New York Academy of Sciences, 1493(1), 75-89. https://doi.org/10.1111/nyas.14554
- 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
- Négyessy, L., Pálfi, E., Ashaber, M., Palmer, C., Jákli, B., Friedman, R. M., Chen, L. M., & Roe, A. W. (2013). Intrinsic horizontal connections process global tactile features in the primary somatosensory cortex: Neuroanatomical evidence. Journal of Comparative Neurology, 521(12), 2798-2817. https://doi.org/10.1002/cne.23317
- Olana, D. D., Abessa, T. G., Lamba, D., Triccas, L. T., & Bonnechere, B. (2025). 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. Journal of NeuroEngineering and Rehabilitation, 22(1), 92. https://doi.org/10.1186/s12984-025-01603-1
- Pollock, A., Farmer, S. E., Brady, M. C., Langhorne, P., Mead, G. E., Mehrholz, J., & Van Wijck, F. (2014). Interventions for improving upper limb function after stroke. Cochrane Database of Systematic Reviews, 2014(11). https://doi.org/10.1002/14651858.CD010820.pub2
- Quintana, J. M., Padierna, A., & Esteban, C. (2003). Evaluation of the psychometric characteristics of the Spanish version of the Hospital Anxiety and Depression Scale. 107(3), 216-221. https://doi.org/10.1034/j.1600-0447.2003.00062.x
- Schaechter, J. D. (2004). Motor rehabilitation and brain plasticity after hemiparetic stroke. Progress in Neurobiology, 73(1), 61-72. https://doi.org/10.1016/j.pneurobio.2004.04.001
- Serino, A., & Haggard, P. (2010). Touch and the body. Neuroscience & Biobehavioral Reviews, 34(2), 224-236. https://doi.org/10.1016/j.neubiorev.2009.04.004
- Soleimani, M., Ghazisaeedi, M., & Heydari, S. (2024). The efficacy of virtual reality for upper limb rehabilitation in stroke patients: A systematic review and meta-analysis. BMC Medical Informatics and Decision Making, 24(1), 135. https://doi.org/10.1186/s12911-024-02534-y
- Sung, H. J., You, S. H., Hallett, M., Yun, W. C., Park, C. M., Cho, S. H., Lee, H. Y., & Kim, T. H. (2005). Cortical reorganization and associated functional motor recovery after virtual reality in patients with chronic stroke: An experimenter-blind preliminary study. Archives of Physical Medicine and Rehabilitation, 86(11). https://doi.org/10.1016/j.apmr.2005.04.015
- Vilagut, G., & Valderas, J. M. (2008). Interpretación de los cuestionarios de salud SF-36 y SF-12 en España: Componentes físico y mental. 130(19), 726-735. https://doi.org/10.1157/13121076
- Zhang, J. J. Q., Fong, K. N. K., Welage, N., & Liu, K. P. Y. (2018). The activation of the mirror neuron system during action observation and action execution with mirror visual feedback in stroke: A systematic review. In Neural Plasticity (Vol. 2018). https://doi.org/10.1155/2018/2321045
- Zhang, J., Liu, M., Yue, J., Yang, J., Xiao, Y., Yang, J., & Cai, E. (2025). Effects of virtual reality with different modalities on upper limb recovery: A systematic review and network meta-analysis on optimizing stroke rehabilitation. Frontiers in Neurology, 16, 1544135. https://doi.org/10.3389/fneur.2025.1544135
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Ischemic Stroke
- Stroke
- Paresis
- Therapeutics
- Patient Care
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Occupational Therapy
Other Study ID Numbers
- 22/459_E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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